Data / Medical devices / United States / Alphatec Spine, Inc.
Alphatec Spine, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 100 510(k) clearances
Alphatec Spine, Inc. is registered with the FDA (registration 2027467) in Carlsbad, CA, United States. It lists 75 device types. The FDA files 100 510(k) clearances under its listings, the newest dated July 14, 2026. 27 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2027467
- Address
- 1950 Camino Vida Roble, Carlsbad, CA, United States, 92008
- Owner or operator
- ALPHATEC HOLDINGS, INC. (9072657)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- July 20, 1999
- Registered through
- 2027
- Brand names listed
- ALLEZ SPINE Cross Connectors, AMP, AMP II, AMP-LTX System, ATEC A.R.M., ATEC Lateral Navigation Instruments, ATEC Lateral Plate System, ATEC Porous Ti (PTi) Thoracolumbar Spacer System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 14, 2026 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| June 25, 2026 | K253216 | IntraOp Alignment System; CONTOUR3D Bending System | SIN | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| March 25, 2026 | K253615 | Invictus Bands System | OWI | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| February 19, 2026 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | OLO | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| January 11, 2026 | K252842 | SafeOp 3: Neural Informatix System | GWF | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| September 3, 2025 | K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | OVD | Substantially Equivalent | Alphatec Spine | accessdata.fda.gov |
| August 28, 2025 | K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | KWQ | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| July 3, 2025 | K251080 | IdentiTi II Cervical Interbody System | ODP | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| March 4, 2025 | K243461 | Calibrate Interbody Systems | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov | |
| February 3, 2025 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | MAX | Substantially Equivalent | Alphatec Spine | accessdata.fda.gov |
| October 4, 2024 | K242364 | IdentiTi II Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| September 20, 2024 | K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| June 21, 2024 | K241519 | Invictus® Small Stature Spinal Fixation System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| June 6, 2024 | K240951 | Invictus Robotic Navigation Instruments | OLO | Substantially Equivalent | Alphatec Spine | accessdata.fda.gov |
| May 22, 2024 | K240199 | IntraOp Alignment System | OWB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| April 19, 2024 | K234092 | SafeOp 3: Neural Informatix Systeem | GWF | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| February 22, 2024 | K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System | KWQ | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| November 2, 2023 | K232345 | ATEC Posterior Navigated Disc Prep Instruments | OLO | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| October 13, 2023 | K232504 | Calibrate CCX Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| October 6, 2023 | K232173 | Ascend VBR System, Ascend NanoTec VBR System | MQP | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| October 6, 2023 | K232044 | Invictus Robotic Navigation Instruments | OLO | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| September 27, 2023 | K232275 | Invictus® Spinal Fixation System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| September 25, 2023 | K232097 | IdentiTi ALIF Interbody Systems | OVD | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| September 8, 2023 | K232413 | Fusion Robotic Navigation System | OLO | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| July 13, 2023 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| May 9, 2023 | K230721 | ATEC Lateral Plate System | KWQ | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| March 29, 2023 | K223611 | Calibrate LTX Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| March 23, 2023 | K223765 | ATEC Lateral Navigation Instruments | OLO | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| March 13, 2023 | K223350 | Remi Robotic Navigation System | OLO | Substantially Equivalent | Fusion Robotics, LLC | accessdata.fda.gov |
| December 20, 2022 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | PML | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| November 18, 2022 | K222455 | Calibrate LTX Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| November 17, 2022 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem | ODP | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| October 28, 2022 | K223070 | Remi Robotic Navigation System | OLO | Substantially Equivalent | Fusion Robotics, LLC | accessdata.fda.gov |
| October 7, 2022 | K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System | MAX | Substantially Equivalent | Alphatec Spine | accessdata.fda.gov |
| September 23, 2022 | K221821 | ATEC IOM Accessory Instruments | PDQ | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| June 9, 2022 | K220782 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| April 4, 2022 | K214006 | Invictus® Spinal Fixation System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| March 9, 2022 | K213849 | SafeOp 2: Neural Informatix System | GWF | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| December 15, 2021 | K213443 | Insignia Anterior Cervical Plate System | KWQ | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| December 10, 2021 | K213460 | Invictus Spinal Fixation System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| October 29, 2021 | K211987 | ATEC Alignment App | LLZ | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| September 22, 2021 | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| August 10, 2021 | K211873 | PSX Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| April 9, 2021 | K203742 | IdentiTi ALIF Standalone Interbody System | OVD | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| February 24, 2021 | K202184 | Practical Navigation Surgical Guidance System (PNSGS) | OLO | Substantially Equivalent | Practical Navigation, LLC | accessdata.fda.gov |
| December 18, 2020 | K203125 | Invictus OCT Spinal Fixation System | NKG | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| December 18, 2020 | K202812 | IdentiTi Cervical Standalone Interbody System | OVE | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| November 23, 2020 | K203056 | Invictus Spinal Fixation System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| November 6, 2020 | K202587 | ATEC Lateral Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| October 15, 2020 | K202327 | Invictus OsseoScrew® System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| May 22, 2020 | K200936 | Invictus CT Spinal Fixation System | NKG | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| May 21, 2020 | K200995 | Insignia Anterior Cervical Plate System | KWQ | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| December 12, 2019 | K192938 | Invictus Spinal Fixation System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| October 18, 2019 | K191723 | ATEC IOM Accessory Instruments | PDQ | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| August 12, 2019 | K191311 | ATEC Lateral Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| June 3, 2019 | K191185 | Solanas® Posterior OCT Fixation System | NKG | Substantially Equivalent | Alphatec Spine | accessdata.fda.gov |
| March 1, 2019 | K183705 | IdentiTi Porous Ti Interbody System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| February 22, 2019 | K182542 | The EPAD 2 System | GWF | Substantially Equivalent | Safeop Surgical, Inc. | accessdata.fda.gov |
| November 9, 2018 | K182808 | Aspida® Anterior Lumbar Plating System | KWQ | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| September 25, 2018 | K181980 | OsseoScrew System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| August 9, 2018 | K181677 | Kodiak Spinal Fixation System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| November 30, 2017 | K173522 | Solanas® Posterior Stabilization System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| September 8, 2016 | K160958 | Battalion Universal Spacer System | PHM | Substantially Equivalent | Alphatec Spine | accessdata.fda.gov |
| June 10, 2016 | K161363 | Arsenal Spinal Fixation System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| April 29, 2016 | K153603 | Alphatec Navigation Instruments | OLO | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| December 30, 2015 | K152968 | Arsenal Spinal Fixation System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| May 22, 2015 | K143740 | Battalion Universal Spacer System | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| April 30, 2015 | K150913 | INCITE ANCHORED CERVICAL INTERBODY DEVICE | OVE | Substantially Equivalent | Incite Innovation | accessdata.fda.gov |
| January 5, 2015 | K143149 | Arsenal Spinal Fixation System | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| March 13, 2014 | K133221 | ARSENAL SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| May 21, 2013 | K131119 | SOLANAS POSTERIOR STABILIZATION SYSTEM | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| March 5, 2013 | K123993 | SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | OVD | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| February 14, 2013 | K123623 | ILLICO MIS POSTERIOR FIXATION SYSTEM | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| November 28, 2012 | K123218 | ILLICO FS FACET FIXATION SYSTEM | MRW | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| May 4, 2012 | K112671 | STERILCONTAINER SYSTEM | KCT | Substantially Equivalent | Aesculap, Ltd. | accessdata.fda.gov |
| January 25, 2012 | K111634 | XENON(TM) PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| July 12, 2011 | K111076 | SOLANAS AVALON POSTERIOR FIXATION SYSTEM | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| June 2, 2011 | K103205 | BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM | KWP | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| May 25, 2011 | K110588 | LEUCADIA PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Phygen, LLC | accessdata.fda.gov |
| November 5, 2010 | K102820 | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | KWQ | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| July 21, 2010 | K101255 | ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM | KWQ | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| June 18, 2010 | K100685 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| February 17, 2010 | K100138 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| July 8, 2009 | K091189 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| July 7, 2009 | K090779 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| April 29, 2009 | K090228 | ROC LUMBAR PLATING SYSTEM | MNH | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| April 22, 2009 | K090782 | NOVEL ALIF SPINAL SPACER SYSTEM | MAX | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| September 19, 2008 | K081730 | NOVEL CERVICAL SPINAL SPACER SYSTEM | ODP | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| July 3, 2008 | K081158 | ZODIC POLYAXIAL SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| May 21, 2008 | K080699 | NOVEL SPINAL SPACER SYSTEM | MQP | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| November 9, 2007 | K071890 | ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| August 20, 2007 | K071380 | MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM | NKB | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| June 11, 2007 | K070460 | ALLEZ SPINE CROSS CONNECTORS | NKB | Substantially Equivalent | Allez Spine, LLC | accessdata.fda.gov |
| November 10, 2005 | K052201 | SOLANAS POSTERIOR STABILIZATION SYSTEM | KWP | Substantially Equivalent | Alphatec Spine, Inc. | accessdata.fda.gov |
| June 22, 2005 | K050830 | ZODIAC SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | Alphatec/Nexmed | accessdata.fda.gov |
| June 17, 2005 | K051286 | ZODIAC SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | Alphatec/Nexmed | accessdata.fda.gov |
| April 18, 2005 | K050553 | NOVEL VBR SPINAL SYSTEM | MQP | Substantially Equivalent | Alphatec/Nexmed | accessdata.fda.gov |
| October 27, 2004 | K042673 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | Alphatec/Nexmed | accessdata.fda.gov |
| October 7, 2004 | K042201 | NOVEL VBR SPINAL SYSTEM | MQP | Substantially Equivalent | Alphatec/Nexmed | accessdata.fda.gov |
| March 26, 2004 | K033090 | ICON POLYAXIAL PEDICLE SCREW SYSTEM | KWP | Substantially Equivalent | Alphatec Mfg., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 13, 2026 | 98967 | Class II | Ongoing | SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System | Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change. | accessdata.fda.gov |
| January 2, 2026 | 98251 | Class II | Ongoing | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. The | Due a design issue where the navigated array connection geometry is incorrect. | accessdata.fda.gov |
| December 15, 2024 | 96009 | Class II | Ongoing | Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nons | Complaints have been received regarding post-operative implant collapse. | accessdata.fda.gov |
| January 26, 2024 | 93898 | Class II | Ongoing | IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graf | Due to reports of intraoperative graft bolt implantation breakages. | accessdata.fda.gov |
| July 7, 2023 | 92776 | Class II | Ongoing | LIF AMP, Adjustable Awl, REF, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF | Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, inc | accessdata.fda.gov |
| September 14, 2022 | 90940 | Class II | Ongoing | Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15 TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO Trial Tip, 12A X 9P X | Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing. | accessdata.fda.gov |
| April 26, 2021 | 87887 | Class II | Terminated | Atec Insignia Anterior Cervical Plate System, REF, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422 | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | accessdata.fda.gov |
| May 5, 2017 | 77220 | Class II | Terminated | Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerati | Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body. | accessdata.fda.gov |
| October 5, 2016 | 75337 | Class II | Terminated | Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of deg | Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body. | accessdata.fda.gov |
| April 10, 2015 | 70958 | Class II | Terminated | 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, S | During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm recalling the affected lots codes for this mislabeling. | accessdata.fda.gov |
| June 26, 2014 | 68667 | Class II | Terminated | Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the | Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use. | accessdata.fda.gov |
| June 28, 2013 | 65672 | Class II | Terminated | Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and | The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver. | accessdata.fda.gov |
| May 6, 2013 | 65165 | Class II | Terminated | Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments. | Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have b | accessdata.fda.gov |
| September 25, 2012 | 63385 | Class II | Terminated | ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to faci | The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws nonfunctional. | accessdata.fda.gov |
| May 29, 2012 | 51437 | Class II | Terminated | TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development | On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate. | accessdata.fda.gov |
| March 19, 2012 | 61756 | Not yet classified | Terminated | SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion proc | Alphatec Spine has received several complaints (n+4) on the Alphatec Solus Distal Deployment Wrench for twisting or bending, which has been discovered either during or after instrumentation use. A fifth complaint received in which it was reported that the spline tip of the Alphatec Solus Proximal Deployment Wrench had sheared from the instrument upon use. | accessdata.fda.gov |
| July 6, 2011 | 55155 | Class II | Terminated | ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervi | The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length. | accessdata.fda.gov |
| December 9, 2010 | 63599 | Class II | Terminated | TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the su | The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM. | accessdata.fda.gov |
| November 1, 2010 | 59920 | Not yet classified | Terminated | Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization durin | These lots were not manufactured correctly in that the instrument does not have the durability required to repeatedly perform over its full service life and, therefore, may experience breakage in the tips. | accessdata.fda.gov |
| August 25, 2009 | 55613 | Not yet classified | Terminated | Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008. Intended for the temporary stabilization of the anterior spine during the development of fusion in patients. | The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior Cervical Plate implant. | accessdata.fda.gov |
| August 5, 2009 | 53144 | Not yet classified | Terminated | Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12 | Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees. | accessdata.fda.gov |
| May 13, 2009 | 52759 | Not yet classified | Terminated | Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. Spinal fixation system consisting of various shapes or | Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant. | accessdata.fda.gov |
| January 28, 2009 | 51734 | Not yet classified | Terminated | ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520 The ILLICO Posterior Thoracolumbar Access Retractor is an instrument that is intended for use in a minimally invasive approach for surgical procedures. | The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar access retractor. It was reported that one of the retractor arms in the retractor broke during surgery. | accessdata.fda.gov |
| December 16, 2008 | 52760 | Not yet classified | Terminated | ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants. | Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. The actual ROC bolts themselves are correctly laser etched. | accessdata.fda.gov |
| November 3, 2008 | 50685 | Not yet classified | Terminated | Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed com | Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L. | accessdata.fda.gov |
| August 16, 2007 | 48177 | Not yet classified | Terminated | Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or t | Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881. | accessdata.fda.gov |
| May 30, 2002 | 26410 | Not yet classified | Terminated | Alpha Mirage Top Tightening Spinal System 5.5 mm x 45 mm Length Bone Screws | Laser marking is wrong on bone screws, says 40 and is 45 mm long. | accessdata.fda.gov |
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Updated July 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.