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Data / Medical devices / United States / Alphatec Spine, Inc.

Alphatec Spine, Inc.: FDA-registered device maker in Memphis, TN, United States, 98 510(k) clearances

Alphatec Spine, Inc. is registered with the FDA (registration 3019878714) in Memphis, TN, United States. It lists 75 device types. The FDA files 98 510(k) clearances under its listings, the newest dated July 14, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Alphatec Spine, Inc.
FDA registration number
3019878714
Address
4101 Willow Lake Blvd., Memphis, TN, United States, 38118
Owner or operator
ALPHATEC HOLDINGS, INC. (9072657)
Roles
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 Porous Ti (PTi) Thoracolumbar Spacer System, ATEC Posterior Navigated Disc Prep Instruments and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufactureraccessdata.fda.gov
Automated Intraoperative Spinal Rod Bending SystemSIN2Manufactureraccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
BenderHXW1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Manufactureraccessdata.fda.gov
Bone Fixation Cerclage, SublaminarOWI2Manufactureraccessdata.fda.gov
BroachHTQ1Manufactureraccessdata.fda.gov
Cable, ElectrodeIKD2Manufactureraccessdata.fda.gov
CaliperKTZ1Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufactureraccessdata.fda.gov
CuretteHTF1Manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufactureraccessdata.fda.gov
Driver, ProsthesisHWR1Manufactureraccessdata.fda.gov
Electrode, CutaneousGXY2Manufactureraccessdata.fda.gov
Electrode, NeedleGXZ2Manufactureraccessdata.fda.gov
Electromyograph, DiagnosticIKN2Manufactureraccessdata.fda.gov
ElevatorHTE1Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Forceps, Wire HoldingHYA1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Manufactureraccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Manufactureraccessdata.fda.gov
Knife, OrthopedicHTS1Manufactureraccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Manufactureraccessdata.fda.gov
MalletHXL1Manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Manufactureraccessdata.fda.gov
Neurosurgical Nerve LocatorPDQ2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufactureraccessdata.fda.gov
Osteotome, ManualGFI1Manufactureraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
RaspHTR1Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Retractor, FiberopticFDG1Manufactureraccessdata.fda.gov
RongeurHTX1Manufactureraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Manufactureraccessdata.fda.gov
Starter, Bone ScrewHWD1Manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Repackager or relabeleraccessdata.fda.gov
Stimulator, Electrical, Evoked ResponseGWF2Manufactureraccessdata.fda.gov
Stimulator, NerveETN2Manufactureraccessdata.fda.gov
Support, Patient PositionCCX1Manufactureraccessdata.fda.gov
System, Facet Screw Spinal DeviceMRWUManufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Manufactureraccessdata.fda.gov
Table, Operating-Room, Ac-PoweredFQO1Manufacturer, Specification developeraccessdata.fda.gov
Table, Operating-Room, PneumaticFWW1Manufacturer, Specification developeraccessdata.fda.gov
TampHXG1Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
TemplateHWT1Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
TrephineHWK1Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 14, 2026K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
June 25, 2026K253216IntraOp Alignment System; CONTOUR3D Bending SystemSINSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
March 25, 2026K253615Invictus Bands SystemOWISubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
February 19, 2026K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)OLOSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
January 11, 2026K252842SafeOp 3: Neural Informatix SystemGWFSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
September 3, 2025K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemOVDSubstantially EquivalentAlphatec Spineaccessdata.fda.gov
August 28, 2025K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
July 3, 2025K251080IdentiTi II Cervical Interbody SystemODPSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
March 4, 2025K243461Calibrate Interbody SystemsSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
February 3, 2025K241375IdentiTi 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 CerMAXSubstantially EquivalentAlphatec Spineaccessdata.fda.gov
October 4, 2024K242364IdentiTi™ II Interbody SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
September 20, 2024K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
June 21, 2024K241519Invictus® Small Stature Spinal Fixation SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
June 6, 2024K240951Invictus Robotic Navigation InstrumentsOLOSubstantially EquivalentAlphatec Spineaccessdata.fda.gov
May 22, 2024K240199IntraOp Alignment SystemOWBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
April 19, 2024K234092SafeOp 3: Neural Informatix SysteemGWFSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
February 22, 2024K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody SystemKWQSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
November 2, 2023K232345ATEC Posterior Navigated Disc Prep InstrumentsOLOSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
October 13, 2023K232504Calibrate CCX Interbody SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
October 6, 2023K232173Ascend VBR System, Ascend NanoTec VBR SystemMQPSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
October 6, 2023K232044Invictus Robotic Navigation InstrumentsOLOSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
September 27, 2023K232275Invictus® Spinal Fixation SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
September 25, 2023K232097IdentiTi ALIF Interbody SystemsOVDSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
September 8, 2023K232413Fusion Robotic Navigation SystemOLOSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
July 13, 2023K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
March 29, 2023K223611Calibrate LTX Interbody SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
March 23, 2023K223765ATEC Lateral Navigation InstrumentsOLOSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
March 13, 2023K223350Remi Robotic Navigation SystemOLOSubstantially EquivalentFusion Robotics, LLCaccessdata.fda.gov
December 20, 2022K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemPMLSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
November 18, 2022K222455Calibrate LTX Interbody SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
November 17, 2022K222973IdentiTi 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 SytemODPSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
October 28, 2022K223070Remi Robotic Navigation SystemOLOSubstantially EquivalentFusion Robotics, LLCaccessdata.fda.gov
October 7, 2022K222028IdentiTi™ 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 SystemMAXSubstantially EquivalentAlphatec Spineaccessdata.fda.gov
September 23, 2022K221821ATEC IOM Accessory InstrumentsPDQSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
June 9, 2022K220782IdentiTi™ 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 SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
April 4, 2022K214006Invictus® Spinal Fixation SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
March 9, 2022K213849SafeOp 2: Neural Informatix SystemGWFSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
December 15, 2021K213443Insignia™ Anterior Cervical Plate SystemKWQSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
December 10, 2021K213460Invictus Spinal Fixation SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
October 29, 2021K211987ATEC Alignment AppLLZSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
September 22, 2021K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
August 10, 2021K211873PSX Interbody SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
April 9, 2021K203742IdentiTi ALIF Standalone Interbody SystemOVDSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
February 24, 2021K202184Practical Navigation Surgical Guidance System (PNSGS)OLOSubstantially EquivalentPractical Navigation, LLCaccessdata.fda.gov
December 18, 2020K203125Invictus™ OCT Spinal Fixation SystemNKGSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
December 18, 2020K202812IdentiTi Cervical Standalone Interbody SystemOVESubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
November 23, 2020K203056Invictus™ Spinal Fixation SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
November 6, 2020K202587ATEC Lateral Interbody SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
October 15, 2020K202327Invictus™ OsseoScrew® SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
May 22, 2020K200936Invictus™ CT Spinal Fixation SystemNKGSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
May 21, 2020K200995Insignia™ Anterior Cervical Plate SystemKWQSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
December 12, 2019K192938Invictus™ Spinal Fixation SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
October 18, 2019K191723ATEC IOM Accessory InstrumentsPDQSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
August 12, 2019K191311ATEC Lateral Interbody SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
June 3, 2019K191185Solanas® Posterior OCT Fixation SystemNKGSubstantially EquivalentAlphatec Spineaccessdata.fda.gov
March 1, 2019K183705IdentiTi Porous Ti Interbody SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
February 22, 2019K182542The EPAD 2 SystemGWFSubstantially EquivalentSafeop Surgical, Inc.accessdata.fda.gov
November 9, 2018K182808Aspida® Anterior Lumbar Plating SystemKWQSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
September 25, 2018K181980OsseoScrew SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
August 9, 2018K181677Kodiak Spinal Fixation SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
November 30, 2017K173522Solanas® Posterior Stabilization SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
September 8, 2016K160958Battalion Universal Spacer SystemPHMSubstantially EquivalentAlphatec Spineaccessdata.fda.gov
June 10, 2016K161363Arsenal Spinal Fixation SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
April 29, 2016K153603Alphatec Navigation InstrumentsOLOSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
December 30, 2015K152968Arsenal Spinal Fixation SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
May 22, 2015K143740Battalion Universal Spacer SystemMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
April 30, 2015K150913INCITE ANCHORED CERVICAL INTERBODY DEVICEOVESubstantially EquivalentIncite Innovationaccessdata.fda.gov
January 5, 2015K143149Arsenal Spinal Fixation SystemNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
March 13, 2014K133221ARSENAL SPINAL FIXATION SYSTEMNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
May 21, 2013K131119SOLANAS POSTERIOR STABILIZATION SYSTEMNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
March 5, 2013K123993SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMOVDSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
February 14, 2013K123623ILLICO MIS POSTERIOR FIXATION SYSTEMNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
November 28, 2012K123218ILLICO FS FACET FIXATION SYSTEMMRWSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
May 4, 2012K112671STERILCONTAINER SYSTEMKCTSubstantially EquivalentAesculap, Ltd.accessdata.fda.gov
July 12, 2011K111076SOLANAS AVALON POSTERIOR FIXATION SYSTEMNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
June 2, 2011K103205BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEMKWPSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
May 25, 2011K110588LEUCADIA PEDICLE SCREW SYSTEMNKBSubstantially EquivalentPhygen, LLCaccessdata.fda.gov
November 5, 2010K102820APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYKWQSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
July 21, 2010K101255ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEMKWQSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
June 18, 2010K100685ZODIAC POLYAXIAL SPINAL FIXATION SYSTEMKWPSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
February 17, 2010K100138ZODIAC POLYAXIAL SPINAL FIXATION SYSTEMMNISubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
July 8, 2009K091189ZODIAC POLYAXIAL SPINAL FIXATION SYSTEMMNISubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
July 7, 2009K090779ZODIAC POLYAXIAL SPINAL FIXATION SYSTEMMNISubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
April 29, 2009K090228ROC LUMBAR PLATING SYSTEMMNHSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
April 22, 2009K090782NOVEL ALIF SPINAL SPACER SYSTEMMAXSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
September 19, 2008K081730NOVEL CERVICAL SPINAL SPACER SYSTEMODPSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
July 3, 2008K081158ZODIC POLYAXIAL SPINAL FIXATION SYSTEMMNISubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
May 21, 2008K080699NOVEL SPINAL SPACER SYSTEMMQPSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
November 9, 2007K071890ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEMMNHSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
August 20, 2007K071380MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEMNKBSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
June 11, 2007K070460ALLEZ SPINE CROSS CONNECTORSNKBSubstantially EquivalentAllez Spine, LLCaccessdata.fda.gov
November 10, 2005K052201SOLANAS POSTERIOR STABILIZATION SYSTEMKWPSubstantially EquivalentAlphatec Spine, Inc.accessdata.fda.gov
June 22, 2005K050830ZODIAC SPINAL FIXATION SYSTEMKWPSubstantially EquivalentAlphatec/Nexmedaccessdata.fda.gov
June 17, 2005K051286ZODIAC SPINAL FIXATION SYSTEMMNHSubstantially EquivalentAlphatec/Nexmedaccessdata.fda.gov
April 18, 2005K050553NOVEL VBR SPINAL SYSTEMMQPSubstantially EquivalentAlphatec/Nexmedaccessdata.fda.gov
October 27, 2004K042673ZODIAC POLYAXIAL SPINAL FIXATION SYSTEMKWPSubstantially EquivalentAlphatec/Nexmedaccessdata.fda.gov
October 7, 2004K042201NOVEL VBR SPINAL SYSTEMMQPSubstantially EquivalentAlphatec/Nexmedaccessdata.fda.gov
March 26, 2004K033090ICON POLYAXIAL PEDICLE SCREW SYSTEMKWPSubstantially EquivalentAlphatec Mfg., Inc.accessdata.fda.gov

Compare with other makers

Updated July 14, 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.