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Data / Medical devices / Knife, Orthopedic / United States

FDA-registered makers of Knife, Orthopedic in the United States: 41 establishments

41 establishments in the United States are registered with the FDA to make Knife, Orthopedic (product code HTS). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.

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Device
Knife, Orthopedic
Product code
HTS
Country
United States

Makers of Knife, Orthopedic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
4web Inc.Frisco, TX, United StatesSpecification developer0000api.fda.gov
Aegis Meditec, Inc.Costa Mesa, CA, United StatesSpecification developer0000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
B-One Ortho, Corp.Cedar Knolls, NJ, United StatesManufacturer0000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesSpecification developer0020api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Geotec, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, 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
K2M, Inc.Leesburg, VA, United StatesManufacturer, Specification developer0000api.fda.gov
Lacey Manufacturing Company LLCBridgeport, CT, United StatesManufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.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
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Nexus CMFSalt Lake City, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Precision Medical Manufacturing LLCWheeling, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Si-Bone, Inc.Santa Clara, CA, United StatesManufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Swissortho LLCProvidence, RI, United StatesSpecification developer0000api.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
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
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Zimmer Trabecular Metal Technology, Inc.Parsippany, NJ, United StatesManufacturer0000api.fda.gov
b-ONE Ortho Corp.Fairfield, NJ, United StatesSpecification developer0000api.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.