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Data / Medical devices / Rasp / United States

FDA-registered makers of Rasp in the United States: 118 establishments

118 establishments in the United States are registered with the FDA to make Rasp (product code HTR). 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
Rasp
Product code
HTR
Country
United States

Makers of Rasp in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer1September 28, 1977000api.fda.gov
4web Inc.Frisco, TX, United StatesSpecification developer0000api.fda.gov
Alden Tool Company, Inc.Berlin, CT, United StatesContract manufacturer0000api.fda.gov
Alira Medical Devices LLCRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer0000api.fda.gov
ARCH - QuakertownQuakertown, PA, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, 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
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer0000api.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 StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Black & Black Surgical, Inc.Tucker, GA, United StatesSpecification developer0000api.fda.gov
Blustone Synergy, LLCPueblo, CO, United StatesSpecification developer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
C+a Tool Engineering, Inc.Churubusco, IN, United StatesContract manufacturer0000api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Centinel Spine, LLCWest Chester, PA, United StatesSpecification developer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Elevation SpineMonterey, CA, United StatesSpecification developer0000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer0000api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCFlorence, AL, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Flospine LLCBoca Raton, FL, 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
Hammill MFG. Co.Maumee, OH, United StatesContract manufacturer0000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Instrumental Machine & Development, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Intelivation Technologies, LLCPlymouth Meeting, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.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
Integrity SpineSan Antonio, TX, United StatesManufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Kapp Surgical, Inc.Cleveland, OH, United StatesManufacturer0000api.fda.gov
Kalitec Direct LLC DBA Kalitec MedicalSarasota, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Life Instrument Corp.Braintree, MA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
Mach MedicalColumbia City, IN, 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 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
Medline ReNewalRedmond, OR, United StatesReprocessor0010api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Nexus Spine, L.L.C.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Nexus Spine, LLC.Lehi, UT, United StatesSpecification developer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Nvision Biomedical Technologies, IncSan Antonio, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
NanoHive Medical LLCWoburn, MA, United StatesManufacturer, Specification developer0000api.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
Osseus Fusion Systems LLCDallas, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer, 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 Medical TechnologiesRome City, IN, 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
Renovo, Inc.Bend, OR, United StatesReprocessor0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)Alachua, FL, United StatesSpecification developer0000api.fda.gov
Scanlan International, Inc.Saint Paul, MN, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Shalby Advanced Technologies, Inc.El Dorado Hills, CA, United StatesManufacturer0000api.fda.gov
Single Source Medical LLCChurubusco, IN, United StatesContract manufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Spine Wave, Inc.Shelton, CT, United StatesManufacturer, Specification developer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sterramed IncWeehawken, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer0000api.fda.gov
Suretek MedicalGreenville, SC, United StatesReprocessor0000api.fda.gov
Surgentec LLCBoca Raton, FL, United StatesManufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract 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
Tedan Surgical Innovations, Inc.Sugar Land, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Theken Companies, LLCAkron, OH, United StatesSpecification developer0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Tracer OrthopedicsOakland, NJ, United StatesContract manufacturer0000api.fda.gov
Treace Medical Concepts, Inc.Ponte Vedra, FL, United StatesManufacturer0000api.fda.gov
Trigon America LLCAurora, IL, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.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
TriPoint SurgicalColumbia City, IN, United StatesContract manufacturer0000api.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 StatesComplaint file establishment, Manufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Zimmer Trabecular Metal Technology, Inc.Parsippany, NJ, United StatesManufacturer0000api.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.