Data / Medical devices / Impactor / United States

FDA-registered makers of Impactor in the United States: 151 establishments

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

151 establishments in the United States are registered with the FDA to make Impactor (product code HWA). 0 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device: Impactor
Product code: HWA
Country: United States

Makers of Impactor in the United States

Maker	Location	Role	Recall events	Source
4web Inc.	Frisco, TX, United States	Specification developer	0	api.fda.gov
Aegis Meditec, Inc.	Costa Mesa, CA, United States	Specification developer	0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	0	api.fda.gov
Alva Prototypes Inc	Pottstown, PA, United States	Contract manufacturer, Remanufacturer	0	api.fda.gov
Aptis Medical, LLC.	Glenview, KY, United States	Manufacturer	0	api.fda.gov
ARCH Medical Solutions - Elmhurst	Elmhurst, IL, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0	api.fda.gov
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
ARCH-MedTorque	Kenosha, WI, United States	Contract manufacturer	0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0	api.fda.gov
B & J Medical LLC	Kendallville, IN, United States	Contract manufacturer	0	api.fda.gov
B-One Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer	0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract manufacturer	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	1	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Manufacturer for export	0	api.fda.gov
CTL Medical Corporation	Carrollton, TX, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Curiteva, Inc.	Tanner, AL, United States	Contract manufacturer	0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0	api.fda.gov
Degen Medical	Florence, SC, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	1	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	0	api.fda.gov
Djo, LLC	Carlsbad, CA, United States	Specification developer	0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0	api.fda.gov
DT Medtech LLC	McMinnville, TN, United States	Specification developer	0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	3	api.fda.gov
Eptam Plastics, Ltd	Northfield, NH, United States	Contract manufacturer	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer, Repackager or relabeler	3	api.fda.gov
Elite Medical, LLC	Bartlett, TN, United States	Contract manufacturer	0	api.fda.gov
Elite Medical, LLC	Florence, AL, United States	Contract manufacturer	0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0	api.fda.gov
Fetzer Surgical, LLC	Scottsdale, AZ, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Foundation Fusion Solutions, LLC	Tulsa, OK, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Gsource, LLC.	Emerson, NJ, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Holmed LLC	Attleboro, MA, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer, Specification developer	6	api.fda.gov
Haven Manufacturing	Ossian, IN, United States	Contract manufacturer	0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Manufacturer	0	api.fda.gov
Innomed, Inc.	Savannah, GA, United States	Manufacturer, Repackager or relabeler, Specification developer	0	api.fda.gov
Innomed, Inc.	N Manchester, IN, United States	Manufacturer	0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Instrumental Machine & Development, Inc.	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Intelivation Technologies, LLC	Plymouth Meeting, PA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Instrumed International Inc dba Avalign German Specialty Instruments	Schaumburg, IL, United States	Contract manufacturer, Repackager or relabeler	0	api.fda.gov
Integra LifeSciences Production Corporation	Mansfield, MA, United States	Specification developer	0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, PA, United States	Contract manufacturer	0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0	api.fda.gov
K2M, Inc.	Leesburg, VA, United States	Manufacturer, Specification developer	0	api.fda.gov
Kapp Surgical, Inc.	Cleveland, OH, United States	Manufacturer	0	api.fda.gov
Kalitec Direct LLC DBA Kalitec Medical	Sarasota, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Lenox-Maclaren Surgical Corp.	Louisville, CO, United States	Manufacturer	0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0	api.fda.gov
LinkBio Corp.	Dover, NJ, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	Manufacturer, Specification developer	0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Specification developer	0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0	api.fda.gov
Medartis Inc.	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Mendell	Lakeville, MN, United States	Contract manufacturer	0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0	api.fda.gov
Microcision LLC	Pennsauken, NJ, United States	Contract manufacturer	0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0	api.fda.gov
Nuvasive, Inc.	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
NanoHive Medical LLC	Woburn, MA, United States	Manufacturer, Specification developer	0	api.fda.gov
NuVasive Specialized Orthopedics, Inc.	Audubon, PA, United States	Manufacturer	0	api.fda.gov
Oberg Medical Products Company	Sarver, PA, United States	Contract manufacturer	0	api.fda.gov
Orchid Orthopedics-Chelsea	Chelsea, MI, United States	Contract manufacturer	0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Specification developer	0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0	api.fda.gov
Orthopedic Sciences, Inc	Overland Park, KS, United States	Specification developer	0	api.fda.gov
Osteomed	Addison, TX, United States	Manufacturer	0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer	0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0	api.fda.gov
Orthopedic Designs North America, Inc.	Tampa, FL, United States	Manufacturer	0	api.fda.gov
Pacific Instruments Inc.	Honolulu, HI, United States	Contract manufacturer	0	api.fda.gov
Paragon 28	Englewood, CO, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0	api.fda.gov
Perryman Company	Houston, PA, United States	Contract manufacturer	0	api.fda.gov
Phoenix Instruments, Inc.	Lisle, IL, United States	Contract manufacturer	0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0	api.fda.gov
Pioneer Surgical Technology, Inc.	Marquette, MI, United States	Manufacturer	0	api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing Facility	N Manchester, IN, United States	Contract manufacturer	0	api.fda.gov
Precision Spine, Inc.	Pearl, MS, United States	Manufacturer	0	api.fda.gov
ProMed Concepts, LLC	Brighton, TN, United States	Contract manufacturer	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0	api.fda.gov
RSB Spine LLC.	Wooster, OH, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0	api.fda.gov
Seaspine Orthopedics Corporation	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
STERIS Corporation	Saint Louis, MO, United States	Manufacturer	0	api.fda.gov
Sterramed Inc	Weehawken, NJ, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0	api.fda.gov
Theken Companies, LLC	Akron, OH, United States	Specification developer	0	api.fda.gov
TOMZ Corporation	Berlin, CT, United States	Contract manufacturer	0	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Triangle Machine, Inc.	South Bend, IN, United States	Manufacturer	0	api.fda.gov
Trigon America LLC	Aurora, IL, United States	Contract manufacturer	0	api.fda.gov
Trimed, Inc.	Santa Clarita, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0	api.fda.gov
Turner Medical Inc.	Athens, AL, United States	Contract manufacturer	0	api.fda.gov
Teleflex LLC (NADC)	Olive Branch, MS, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Teleflex Medical LLC	Morrisville, NC, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Titan Spine, a Division of Medtronic	Milwaukee, WI, United States	Manufacturer	0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Ulrich Medical Usa, Inc.	Plano, TX, United States	Specification developer	0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0	api.fda.gov
Viant Upland, Inc	Upland, CA, United States	Contract manufacturer	0	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	Manufacturer	0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Xtant Medical Holdings, Inc.	Belgrade, MT, United States	Repackager or relabeler, Specification developer	1	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	2	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	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.