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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Spinal Simplicity, LLCOverland Park, KS, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer7December 1, 2025000api.fda.gov
Aurora Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer4July 8, 2022000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer4March 5, 2015000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesManufacturer4March 5, 2015000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer3May 4, 2016000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer2May 21, 2018000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2February 22, 2018000api.fda.gov
Amplio SpineBoca Raton, FL, United StatesSpecification developer1October 19, 2023000api.fda.gov
Flospine LLCBoca Raton, FL, United StatesManufacturer1October 19, 2023000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer1March 7, 2014000api.fda.gov
Kalitec Direct LLC DBA Kalitec MedicalSarasota, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1March 16, 2017000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer1July 28, 2016000api.fda.gov
Spineology Inc.Saint Paul, MN, United StatesManufacturer1September 10, 2014000api.fda.gov
Wenzel SpineAustin, TX, United StatesSpecification developer1August 15, 2023000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification developer1June 27, 2013010api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Manufacturer, Specification developer1October 19, 2016000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Aurora Spine ManufacturingCarlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupEagleville, PA, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupLimerick, PA, United StatesContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer0000api.fda.gov
Curiteva, Inc.Tanner, AL, United StatesContract manufacturer0000api.fda.gov
Eptam Plastics, LtdNorthfield, NH, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCFlorence, AL, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Hammill MFG. Co.Maumee, OH, United StatesContract manufacturer0000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
NML Medical, LLCWest Carrollton, OH, United StatesContract manufacturer0000api.fda.gov
Odyssey Medical Technologies, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
SPINEFRONTIER, INC. DBA LESspine InnovationsBurlington, MA, United StatesManufacturer0000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
TOMZ CorporationBerlin, CT, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.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.