Data / Medical devices / Instrument, Compression / United States

FDA-registered makers of Instrument, Compression in the United States: 79 establishments

Name: FDA-registered makers of Instrument, Compression in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

79 establishments in the United States are registered with the FDA to make Instrument, Compression (product code HWN). 1 has 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: Instrument, Compression
Product code: HWN
Country: United States

Makers of Instrument, Compression in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	1	December 5, 1979	0	api.fda.gov
Aegis Meditec, Inc.	Costa Mesa, CA, United States	Specification developer	0		0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Elmhurst	Elmhurst, IL, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Axia Orthopedics	Portland, OR, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract manufacturer	0		0	api.fda.gov
Biogennix, LLC	Irvine, CA, United States	Specification developer	0		0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
CTL Medical Corporation	Carrollton, TX, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	0		0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	0		0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	0		0	api.fda.gov
Elite Medical, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Elite Medical, LLC	Florence, AL, United States	Contract manufacturer	0		0	api.fda.gov
Flospine LLC	Boca Raton, FL, United States	Manufacturer	0		0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Hammill MFG. Co.	Maumee, OH, United States	Contract manufacturer	0		0	api.fda.gov
Holmed LLC	Attleboro, MA, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0		0	api.fda.gov
HyperFlex Medical Inc	Richmond, UT, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Infigo Medical	Miami, FL, United States	Manufacturer for export, Repackager or relabeler	0		0	api.fda.gov
Instrumental Machine & Development, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Intelivation Technologies, LLC	Plymouth Meeting, PA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, PA, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Elmira)	Horseheads, NY, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	api.fda.gov
K2M, Inc.	Leesburg, VA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Kalitec Direct LLC DBA Kalitec Medical	Sarasota, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Lenox-Maclaren Surgical Corp.	Louisville, CO, United States	Manufacturer	0		0	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0		0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	0		0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Reprocessor	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Nuvasive, Inc.	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
NuVasive Specialized Orthopedics, Inc.	Audubon, PA, United States	Manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	0		0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Osteomed	Addison, TX, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Orthopedic Designs North America, Inc.	Tampa, FL, United States	Manufacturer	0		0	api.fda.gov
Pacific Instruments Inc.	Honolulu, HI, United States	Contract manufacturer	0		0	api.fda.gov
Paragon 28	Englewood, CO, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	api.fda.gov
Pioneer Surgical Technology, Inc.	Marquette, MI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Precision Spine, Inc.	Pearl, MS, United States	Manufacturer	0		0	api.fda.gov
Relja Innovations, Inc	Wauwatosa, WI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Seaspine Orthopedics Corporation	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Sterramed Inc	Weehawken, NJ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Structure Medical, LLC.	Naples, FL, United States	Contract manufacturer	0		0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Structure Medical, LLC.	Mooresville, NC, United States	Contract manufacturer	0		0	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	0		0	api.fda.gov
Treace Medical Concepts, Inc.	Ponte Vedra, FL, United States	Manufacturer	0		0	api.fda.gov
Trimed, Inc.	Santa Clarita, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer	0		0	api.fda.gov
Wolf X-Ray Corp	Battleboro, NC, United States	Manufacturer	0		0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Specification developer	0		0	api.fda.gov
Xenix Medical	Orlando, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Xtant Medical Holdings, Inc.	Belgrade, MT, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	0		1	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	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.