Data / Medical devices / Spinous Process Plate / United States
FDA-registered makers of Spinous Process Plate in the United States: 48 establishments
48 establishments in the United States are registered with the FDA to make Spinous Process Plate (product code PEK). 16 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Spinous Process Plate
- Product code
- PEK
- Country
- United States
Makers of Spinous Process Plate in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Spinal Simplicity, LLC | Overland Park, KS, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 7 | December 1, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aurora Spine, Inc. | Carlsbad, CA, United States | Manufacturer, Specification developer | 4 | July 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 4 | March 5, 2015 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Manufacturer | 4 | March 5, 2015 | 0 | 0 | 0 | api.fda.gov |
| Precision Spine, Inc. | Pearl, MS, United States | Manufacturer | 3 | May 4, 2016 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 2 | May 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Seaspine Orthopedics Corporation | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | February 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Amplio Spine | Boca Raton, FL, United States | Specification developer | 1 | October 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Flospine LLC | Boca Raton, FL, United States | Manufacturer | 1 | October 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 1 | March 7, 2014 | 0 | 0 | 0 | api.fda.gov |
| Kalitec Direct LLC DBA Kalitec Medical | Sarasota, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | March 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Spinal Elements, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 1 | July 28, 2016 | 0 | 0 | 0 | api.fda.gov |
| Spineology Inc. | Saint Paul, MN, United States | Manufacturer | 1 | September 10, 2014 | 0 | 0 | 0 | api.fda.gov |
| Wenzel Spine | Austin, TX, United States | Specification developer | 1 | August 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Xtant Medical Holdings, Inc. | Belgrade, MT, United States | Repackager or relabeler, Specification developer | 1 | June 27, 2013 | 0 | 1 | 0 | api.fda.gov |
| Zavation | Flowood, MS, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 19, 2016 | 0 | 0 | 0 | api.fda.gov |
| Aps Materials, Inc. | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axial Medical | Ivyland, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aurora Spine Manufacturing | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Eagleville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Limerick, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bradshaw Medical Inc. | Kenosha, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Curiteva, Inc. | Tanner, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam Plastics, Ltd | Northfield, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Florence, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| First Article Inc | Souderton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flex-Cell Precision, Inc. | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hammill MFG. Co. | Maumee, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J & J Precision Technologies, LLC | Lititz, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LH Medical Corporation | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mainstream Medical Devices | Austin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microcision LLC | Pennsauken, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NML Medical, LLC | West Carrollton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Odyssey Medical Technologies, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Packaging Compliance Medical, LLC | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SPINEFRONTIER, INC. DBA LESspine Innovations | Burlington, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Spine | Allendale, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TOMZ Corporation | Berlin, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victoria Precision Inc. | Trevose, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.