Data / Medical devices / Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment / United States

FDA-registered makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment in the United States: 143 establishments

Name: FDA-registered makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

143 establishments in the United States are registered with the FDA to make Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (product code HWE). 11 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 3, 2026.

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Device: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Product code: HWE
Country: United States

Makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Class I	Source
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	7	August 15, 1996	0	0	api.fda.gov
Depuy Orthopaedics	Bridgewater, MA, United States	Manufacturer, Repackager or relabeler	4	January 5, 2005	0	0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer, Specification developer	2	March 20, 1996	3	0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	2	January 5, 2005	2	0	api.fda.gov
The Anspach Effort, Inc.	Palm Bch Gdns, FL, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	2	January 16, 2007	3	1	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	1	January 25, 1994	0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	1	June 10, 1988	0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	1	June 10, 1988	0	0	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	1	January 20, 2011	0	0	api.fda.gov
Mcginley Orthopaedic Innovations, Inc	Casper, WY, United States	Complaint file establishment, Manufacturer, Specification developer	1	February 20, 2015	0	0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	1	May 26, 2005	0	0	api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)	Riviera Beach, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
3Spine, Inc.	Chattanooga, TN, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Acumed LLC	Hillsboro, OR, United States	Specification developer	0		0	0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	0		0	0	api.fda.gov
American Surgical Company, LLC	Beverly, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Elmhurst	Elmhurst, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Armm, Inc.	Huntington Beach, CA, United States	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Arthrosurface, Inc.	W Bridgewater, MA, United States	Manufacturer	0		0	0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Axia Orthopedics	Portland, OR, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Arthrex California Technology, Incorporated	Santa Barbara, CA, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Arthrex Logistic Center	Fort Myers, FL, United States	Manufacturer	0		0	0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Benchmark Electronics, Inc.	Winona, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	0		1	0	api.fda.gov
C&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Conmed Corporation	Utica, NY, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Command Medical Products, LLC.	Ormond Beach, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	0		0	0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	0		0	0	api.fda.gov
Eca Medical Instruments	Newbury Park, CA, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	0		1	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Extremity Medical, LLC	Parsippany, NJ, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0		0	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
High-Tech Quality MFG. Inc.	Salt Lake City, UT, United States	Contract manufacturer	0		0	0	api.fda.gov
Huron Tool & Cutter Grinding	Farmingdale, NY, United States	Contract manufacturer	0		0	0	api.fda.gov
Hydrocision, Inc.	Billerica, MA, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
HyperFlex Medical Inc	Richmond, UT, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Jabil Inc.	Auburn Hills, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Jabil Inc. (Elmira)	Horseheads, NY, United States	Contract manufacturer	0		0	0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	0	api.fda.gov
K2M, Inc.	Leesburg, VA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
Keystone Manufacturing	Kalamazoo, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Kimball Solutions - Indianapolis	Indianapolis, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Linemaster Switch Corp.	Woodstock, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
LinkBio Corp.	Dover, NJ, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Mac Machine Company	Baltimore, MD, United States	Contract manufacturer	0		0	0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Mci Medical Concept Innovation Inc.	Sunrise, FL, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Medtronic Powered Surgical Solutions	Fort Worth, TX, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Medtronic Puerto Rico Operations Co., Humacao	Humacao, PR, United States	Manufacturer	0		0	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	0		1	0	api.fda.gov
Medtronic Xomed, Inc.	Jacksonville, FL, United States	Manufacturer	0		0	0	api.fda.gov
Microaire Surgical Instruments LLC	Charlottesville, VA, United States	Manufacturer	0		0	0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Reprocessor	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Repackager or relabeler, Reprocessor	0		0	0	api.fda.gov
Metal Components LLC	Grand Rapids, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Nypro Inc (Maple Grove)	Maple Grove, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Orthopedic Sciences, Inc	Overland Park, KS, United States	Specification developer	0		0	0	api.fda.gov
Osteofit LLC	Fairfield, NJ, United States	Specification developer	0		0	0	api.fda.gov
Osteomed	Addison, TX, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Osteoremedies, LLC	Memphis, TN, United States	Specification developer	0		0	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Phoenix Medical Products, Inc.	Mountain City, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Pivot - Edm	La Vista, NE, United States	Contract manufacturer	0		0	0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Pro-Dex, Inc.	Irvine, CA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	0	api.fda.gov
Pivot International	Lenexa, KS, United States	Specification developer	0		0	0	api.fda.gov
Precision Edge Surgical Products Co LLC	Boyne City, MI, United States	Manufacturer for export	0		0	0	api.fda.gov
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Pro-Dex Inc	Tustin, CA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
ProMed Concepts, LLC	Brighton, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Renovo, Inc.	Bend, OR, United States	Reprocessor	0		0	0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
SIGN Fracture Care International	Richland, WA, United States	Manufacturer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	Specification developer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Mansfield, MA, United States	Manufacturer, Specification developer	0		1	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Steripack Usa (limited) LLC	Lakeland, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Stryker Manufacturing Kalamazoo	Portage, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Stryker Puerto Rico, LLC.	Arroyo, PR, United States	Contract manufacturer	0		0	0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Lansing, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Techtronic Industries Medical	Anderson, SC, United States	Contract manufacturer	0		0	0	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Theken Companies, LLC	Akron, OH, United States	Specification developer	0		0	0	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	0		0	0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Trax Surgical, Inc.	Stoughton, MA, United States	Manufacturer	0		0	0	api.fda.gov
Treace Medical Concepts, Inc.	Ponte Vedra, FL, United States	Manufacturer	0		0	0	api.fda.gov
Triangle Machine, Inc.	South Bend, IN, United States	Manufacturer	0		0	0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Turner Medical Inc.	Athens, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Tegra Medical	Hernando, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant Medical, Inc.	Grand Rapids, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer	0		0	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	0		0	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Xtant Medical Holdings, Inc.	Belgrade, MT, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	0		1	0	api.fda.gov

Updated November 3, 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.