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Data / Medical devices / Passer, Wire, Orthopedic / United States

FDA-registered makers of Passer, Wire, Orthopedic in the United States: 64 establishments

64 establishments in the United States are registered with the FDA to make Passer, Wire, Orthopedic (product code HXI). 1 has a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.

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Device
Passer, Wire, Orthopedic
Product code
HXI
Country
United States

Makers of Passer, Wire, Orthopedic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer1May 20, 2014000api.fda.gov
Acumed LLCHillsboro, OR, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Aegis Meditec, Inc.Costa Mesa, CA, United StatesSpecification developer0000api.fda.gov
Alden Tool Company, Inc.Berlin, CT, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer0000api.fda.gov
DT Medtech LLCMcMinnville, TN, United StatesSpecification developer0000api.fda.gov
Extremity Medical, LLCParsippany, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0010api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus FlowerHorsham, PA, United StatesSpecification developer0000api.fda.gov
Fort Wayne Metals Research Products, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Genesys SpineAustin, TX, United StatesManufacturer0000api.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
In2bones Usa, LLCCordova, TN, United StatesSpecification developer0000api.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
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
K2M, Inc.Leesburg, VA, United StatesManufacturer, Specification developer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Kalitec Direct LLC DBA Kalitec MedicalSarasota, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Medical Component SpecialistsBellingham, MA, United StatesContract manufacturer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesSpecification developer0000api.fda.gov
Orthopedic Sciences, IncOverland Park, KS, United StatesSpecification developer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer0000api.fda.gov
Panorthopaedics, Inc.Atlanta, GA, United StatesSpecification developer0000api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer0010api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Parametrics Medical, LLCLeander, TX, United StatesSpecification developer0000api.fda.gov
Pioneer Surgical Technology, Inc.Marquette, MI, United StatesManufacturer0000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Renovo, Inc.Bend, OR, United StatesReprocessor0000api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)Alachua, FL, United StatesSpecification developer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
Tegra Medical - Dartmouth, MADartmouth, MA, United StatesContract manufacturer0000api.fda.gov
Tegra Medical - Franklin, MAFranklin, MA, 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
Vilex LLCMcminnville, TN, United StatesManufacturer0000api.fda.gov
West-Conn Tool And Die IncShelton, CT, United StatesContract manufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0000api.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.