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Data / Medical devices / Osteotome / United States

FDA-registered makers of Osteotome in the United States: 90 establishments

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

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Device
Osteotome
Product code
HWM
Country
United States

Makers of Osteotome in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
4web Inc.Frisco, TX, United StatesSpecification developer0000api.fda.gov
Alva Prototypes IncPottstown, PA, United StatesContract manufacturer, Remanufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH-MedTorqueKenosha, WI, United StatesContract manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Black & Black Surgical, Inc.Tucker, GA, United StatesSpecification developer0000api.fda.gov
Buxton Biomedical, Inc.East Hanover, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Cislak Manufacturing, Inc.Niles, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer0000api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Flospine LLCBoca Raton, FL, United StatesManufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Fischer Surgical Inc.Imperial, MO, United StatesManufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Holmed LLCAttleboro, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
Innomed, Inc.Savannah, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Instrumental Machine & Development, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Life Instrument Corp.Braintree, MA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Mac Machine CompanyBaltimore, MD, United StatesContract manufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MEDBIO - Clinton TownshipClinton Township, MI, United StatesContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesReprocessor0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Medartis Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesSpecification developer0000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer0000api.fda.gov
ProMed Concepts, LLCBrighton, TN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
S.S. White Technologies, Inc. / Dba Shukla MedicalSt Petersburg, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Single Source Medical LLCChurubusco, IN, United StatesContract manufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Sterramed IncWeehawken, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesSpecification developer0000api.fda.gov
Tecomet, Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Treace Medical Concepts, Inc.Ponte Vedra, FL, United StatesManufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Titan Spine, a Division of MedtronicMilwaukee, WI, United StatesManufacturer0000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Zimmer Trabecular Metal Technology, Inc.Parsippany, NJ, United StatesManufacturer0000api.fda.gov
rms SurgicalAnoka, MN, 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.