Data / Medical devices / United States / Warsaw Orthopedic, Inc.
Warsaw Orthopedic, Inc.: FDA-registered device maker in Warsaw, IN, United States, 313 510(k) clearances and 6 PMA approvals
Warsaw Orthopedic, Inc. is registered with the FDA (registration 1824199) in Warsaw, IN, United States. It lists 85 device types. The FDA files 313 510(k) clearances and 6 PMA approvals under its listings, the newest dated July 17, 2026. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1824199
- Address
- 2500 Silveus Xing, Warsaw, IN, United States, 46582
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- February 15, 1978
- Registered through
- 2027
- Brand names listed
- , MOTORS, ACPii Atlantis Cervial Plate, AFFINITY, ANTERIOR CERVICAL PLATE SYSTEM, ARCHITEX, ARTHROSCOPE, ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS" Anterior Cervical Plate System, ATLANTIS- Anterior Cervical Plate 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. Newest 100 of 313.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 17, 2026 | K253011 | Catalyft PL Expandable Interbody System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 14, 2026 | K261020 | Symmetrix L Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 21, 2026 | K254165 | Infinity OCT System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 24, 2025 | K253335 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 26, 2023 | K231184 | CD Horizon Spinal System | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 25, 2022 | K221244 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 24, 2021 | K210425 | Catalyft PL Expandable Interbody System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 30, 2021 | K210637 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| January 15, 2021 | K203678 | CD HORIZON Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 8, 2020 | K202328 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 19, 2020 | K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement | PML | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| October 3, 2019 | K191066 | CD Horizon Astute Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 4, 2019 | K183197 | PYRAMESH Implant System | MQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 11, 2019 | K182928 | CD Horizon Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 29, 2018 | K182119 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 17, 2018 | K181111 | Navigated INFINITY Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 18, 2018 | K180851 | VERTEX Reconstruction System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| March 8, 2018 | K173249 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 18, 2018 | K173338 | Navigated INFINITY Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 19, 2017 | K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 21, 2017 | K163375 | INFINITY OCT System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 13, 2017 | K171468 | FUSE Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| May 11, 2017 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 20, 2016 | K163301 | CD HORIZON® Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 16, 2016 | K162379 | CD HORIZON® Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 12, 2016 | K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems | OUR | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| March 7, 2016 | K160418 | PERIMETER Interbody Fusion Device | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| March 2, 2016 | K153438 | PERIMETER C (Titanium) Spinal System | ODP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 18, 2016 | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 10, 2016 | K153589 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 13, 2015 | K152277 | PIVOX(tm) Oblique Lateral Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 12, 2015 | K152623 | ATLANTIS Anterior Cervical Plate System | KWQ | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 5, 2015 | K152248 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 27, 2015 | K152457 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 11, 2015 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 9, 2015 | K142559 | ELEVATE Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 25, 2015 | K150200 | CD HORIZON Growth Rod Conversion Set | PGM | Substantially Equivalent | Medtronic Sofamor Danek USA, Incorporated | accessdata.fda.gov |
| February 13, 2015 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 12, 2015 | K143628 | Navigated Vertex Select Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 12, 2015 | K143569 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 11, 2015 | K150178 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 6, 2015 | K143471 | VERTEX Reconstruction System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 21, 2015 | K141599 | DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM | OVE | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 4, 2014 | K141632 | ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 1, 2014 | K143141 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 1, 2014 | K142591 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 27, 2014 | K142847 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danck USA, Inc. | accessdata.fda.gov |
| October 21, 2014 | K141604 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 1, 2014 | K142450 | DIVERGENCE Anterior Cervical Fusion System | ODP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 9, 2014 | K140417 | DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| March 25, 2014 | K140449 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| December 20, 2013 | K133650 | CAPSTONE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 11, 2013 | K132897 | CLYDESDALE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| December 6, 2013 | K132328 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 4, 2013 | K132584 | PERIMETER C SPINAL SYSTEM | ODP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 25, 2013 | K132639 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 8, 2013 | K132471 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 6, 2013 | K132111 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| June 5, 2013 | K131321 | CD HORIZON SPINAL SYSTEM | OSH | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| June 4, 2013 | K130640 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 10, 2013 | K130646 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 1, 2013 | K123906 | VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 25, 2013 | K123656 | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 18, 2012 | K123568 | VERTEX RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 16, 2012 | K123246 | CD HORIZON SPIRE Z SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek | accessdata.fda.gov |
| October 3, 2012 | K122862 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 28, 2012 | K122433 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| August 29, 2012 | K121760 | CAPSTONE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 21, 2012 | K121764 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| July 26, 2012 | K121982 | SOVEREIGN SPINAL SYSTEM | OVD | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| July 5, 2012 | K121680 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 29, 2012 | K121333 | WAVE D CAGE | MAX | Substantially Equivalent | Advanced Medical Technologies AG | accessdata.fda.gov |
| June 29, 2012 | K121332 | LOOP CAGE | MAX | Substantially Equivalent | Advanced Medical Technologies AG | accessdata.fda.gov |
| June 29, 2012 | K121330 | WAVE O CAGE | MAX | Substantially Equivalent | Advanced Medical Technologies AG | accessdata.fda.gov |
| June 29, 2012 | K121288 | FUSE CAGE | MAX | Substantially Equivalent | Advanced Medical Technologies AG | accessdata.fda.gov |
| June 29, 2012 | K121191 | VERTEX RCCONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| May 29, 2012 | K110472 | SI-FIX SACROILIAC JOINT FUSION SYSTEM | OUR | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| February 9, 2012 | K113529 | CD HORIZON VOYAGER SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek | accessdata.fda.gov |
| November 21, 2011 | K113174 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 9, 2011 | K110562 | TELAMON PEEK SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| October 26, 2011 | K111520 | IPC POWEREASE SYSTEM | HBE | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| October 21, 2011 | K112473 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| October 4, 2011 | K110063 | SOVEREIGN SPINAL SYSTEM | OVD | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| September 27, 2011 | K112555 | CD HORIZON(R) SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 15, 2011 | K111510 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| August 30, 2011 | K111942 | TSRH SPINAL SYSTEMS | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 24, 2011 | K111525 | PERIMETER INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 9, 2011 | K110543 | CRESCENT (R) SPINAL SYSTEM TITANIUM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 18, 2011 | K103731 | CAPSTONE R SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| May 23, 2011 | K110676 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| April 13, 2011 | K110259 | ARCHITEX SPACE MAINTENANCE SYSTEM | JEY | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 23, 2010 | K103049 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 13, 2010 | K100779 | SUSTAIN SPACE MAINTENANCE SYSTEM | JEY | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 17, 2010 | K102807 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| November 17, 2010 | K102555 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 30, 2010 | K101772 | TSRH(R) SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| June 30, 2010 | K094042 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | OVE | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| June 22, 2010 | K101074 | MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 30, 2010 | K091797 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 15, 2009 | K092325 | MODIFICATION TO:CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 24, 2014 | P090029 | PRESTIGE LP CERVICAL DISC | MJO | 20 | August 9, 2024 | accessdata.fda.gov |
| May 12, 2009 | P060023 | BRYAN CERVICAL DISC PROSTHESIS | MJO | 7 | March 18, 2020 | accessdata.fda.gov |
| July 16, 2007 | P060018 | PRESTIGE CERVICAL DISC SYSTEM | MJO | 5 | August 11, 2016 | accessdata.fda.gov |
| July 2, 2002 | P000058 | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE | NEK | 90 | August 26, 2026 | accessdata.fda.gov |
| June 13, 2002 | P000028 | AFFINITY (TM) CAGE SYSTEM | MAX | 7 | July 25, 2006 | accessdata.fda.gov |
| May 14, 1999 | P970015 | INTER FIX THREADED FUSION DEVICE | MAX | 22 | July 27, 2005 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 31, 2008 | 50185 | Not yet classified | Terminated | Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for de | The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation. | accessdata.fda.gov |
| September 10, 2007 | 44854 | Not yet classified | Terminated | Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138. | Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced. | accessdata.fda.gov |
| September 4, 2007 | 39409 | Not yet classified | Terminated | Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575. | Packaging weakness may compromise sterility and instructions for use are inadequate. | accessdata.fda.gov |
| June 20, 2005 | 32511 | Not yet classified | Terminated | Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016. | The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design. | accessdata.fda.gov |
| May 27, 2005 | 32281 | Not yet classified | Terminated | Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423. | The product is labeled as sterile, but this lot was not sterilized. | accessdata.fda.gov |
| January 4, 2005 | 30854 | Not yet classified | Terminated | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number. | The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit. | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Posterior Metal/Polymer Spinal System, Fusion
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Thoracolumbosacral Pedicle Screw System
Updated July 17, 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.