Data / Medical devices / Rod, Fixation, Intramedullary And Accessories / United States

FDA-registered makers of Rod, Fixation, Intramedullary And Accessories in the United States: 129 establishments

Name: FDA-registered makers of Rod, Fixation, Intramedullary And Accessories in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

129 establishments in the United States are registered with the FDA to make Rod, Fixation, Intramedullary And Accessories (product code HSB). 37 have a 510(k) clearance or PMA approval on file and 14 have a recall event. FDA data exported November 2, 2026.

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Device: Rod, Fixation, Intramedullary And Accessories
Product code: HSB
Country: United States

Makers of Rod, Fixation, Intramedullary And Accessories in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	32	June 10, 2015	13	api.fda.gov
NuVasive Specialized Orthopedics, Inc.	Audubon, PA, United States	Manufacturer, Manufacturer for export	31	December 15, 2023	5	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	30	August 1, 2024	7	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	26	March 20, 2026	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	16	March 12, 2026	15	api.fda.gov
Nuvasive, Inc.	Guaynabo, PR, United States	Manufacturer	15	August 29, 2023	0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Repackager or relabeler, Specification developer	14	April 10, 2025	2	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	12	December 9, 2024	5	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	11	December 9, 2024	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	9	November 23, 2016	0	api.fda.gov
Acumed LLC	Hillsboro, OR, United States	Manufacturer	7	February 5, 2015	2	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	7	September 24, 2026	5	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Specification developer	6	December 1, 1988	1	api.fda.gov
Ortho Precision Products	Hawthorne, CA, United States	Contract manufacturer, Manufacturer	6	October 2, 2012	0	api.fda.gov
Paragon 28	Englewood, CO, United States	Complaint file establishment, Manufacturer, Specification developer	6	March 5, 2026	2	api.fda.gov
Orthopedic Designs North America, Inc.	Tampa, FL, United States	Manufacturer	5	November 5, 2024	0	api.fda.gov
SIGN Fracture Care International	Richland, WA, United States	Manufacturer	5	July 20, 2017	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	4	June 18, 2026	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	4	June 18, 2026	0	api.fda.gov
Medshape, Inc.	Atlanta, GA, United States	Complaint file establishment, Specification developer	4	September 12, 2025	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer, Manufacturer for export	4	February 10, 2015	3	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	4	February 10, 2015	0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer, Manufacturer	3	February 24, 2017	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	3	June 1, 1998	0	api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower	Horsham, PA, United States	Specification developer	3	November 21, 2022	2	api.fda.gov
The Orthopaedic Implant Company	Reno, NV, United States	Specification developer	3	July 27, 2018	0	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	3	October 31, 2023	0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	3	October 31, 2023	1	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	Manufacturer	3	January 30, 2024	1	api.fda.gov
GLW, Inc.	Englewood Cliffs, NJ, United States	Complaint file establishment, Specification developer	2	October 27, 2022	0	api.fda.gov
Orthopedic Generations LLC	Mokena, IL, United States	Specification developer	2	May 13, 2022	0	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Manufacturer	1	September 14, 2017	0	api.fda.gov
Fusion Orthopedics Usa, LLC	Mesa, AZ, United States	Complaint file establishment, Specification developer	1	March 18, 2026	0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Complaint file establishment, Manufacturer	1	December 21, 2021	0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	1	November 13, 2009	0	api.fda.gov
Skeletal Dynamics, Inc	Miami, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	1	June 29, 2010	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	1	October 19, 2012	0	api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)	Riviera Beach, FL, United States	Contract manufacturer	0		0	api.fda.gov
4web Inc.	Frisco, TX, United States	Specification developer	0		0	api.fda.gov
Alden Tool Company, Inc.	Berlin, CT, United States	Contract manufacturer	0		0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Elmhurst	Elmhurst, IL, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH-MedTorque	Kenosha, WI, United States	Contract manufacturer	0		0	api.fda.gov
Artifex Solutions, LLC	San Juan, PR, United States	Contract manufacturer	0		0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
B & J Medical LLC	Kendallville, IN, United States	Contract manufacturer	0		0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract manufacturer	0		0	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer	0		0	api.fda.gov
Branch Medical Group	Eagleville, PA, United States	Contract manufacturer	0		0	api.fda.gov
Branch Medical Group	Limerick, PA, United States	Contract manufacturer	0		0	api.fda.gov
Bradshaw Medical Inc.	Kenosha, WI, United States	Contract manufacturer	0		0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	api.fda.gov
Eptam Plastics, Ltd	Northfield, NH, United States	Contract manufacturer	0		0	api.fda.gov
Eptam West LLC	Colorado Springs, CO, United States	Contract manufacturer	0		0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Ferry Machine Corporation	Oakland, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	api.fda.gov
Fruh Packaging Inc.	Exton, PA, United States	Contract manufacturer	0		0	api.fda.gov
Ferry Machine Corporation	Little Ferry, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0		0	api.fda.gov
Guardian Medical Usa, Inc	Swanton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Harwood Design, Inc.	Bristol, PA, United States	Contract manufacturer	0		0	api.fda.gov
Huron Tool & Cutter Grinding	Farmingdale, NY, United States	Contract manufacturer	0		0	api.fda.gov
Illuminoss Medical Inc.	East Providence, RI, United States	Manufacturer for export	0		0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
J&B Precision, Inc.	Cordova, TN, United States	Contract manufacturer	0		0	api.fda.gov
Jatex, Inc.	Nappanee, IN, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, PA, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Elmira)	Horseheads, NY, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
LaVezzi Precision, Inc	Bloomingdale, IL, United States	Contract manufacturer	0		0	api.fda.gov
Mackay Manufacturing, Inc.	Spokane Valley, WA, United States	Contract manufacturer	0		0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	api.fda.gov
Micro Precision Swiss	Santa Ana, CA, United States	Contract manufacturer	0		0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
Mount MFG	Marquette, MI, United States	Contract manufacturer	0		0	api.fda.gov
Medartis Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Mendell	Lakeville, MN, United States	Contract manufacturer	0		0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Nuvasive, Inc.	San Diego, CA, United States	Manufacturer for export	0		0	api.fda.gov
Odyssey Medical Technologies, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	api.fda.gov
Packaging Compliance Medical, LLC	Kentwood, MI, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
PDV MedTech	Morgan Hill, CA, United States	Contract manufacturer	0		0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	api.fda.gov
Precision Medical Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Precision Medical Technologies	Rome City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Castleton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Precision Edge Surgical Products Co LLC	Boyne City, MI, United States	Contract manufacturer	0		0	api.fda.gov
Quadm Technologies, LLC	Hamilton, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
Quintus, Inc.	Camp Verde, AZ, United States	Contract manufacturer	0		0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	api.fda.gov
RMS Co.	Minneapolis, MN, United States	Contract manufacturer	0		0	api.fda.gov
RevZero, Inc.	Chanhassen, MN, United States	Contract manufacturer	0		0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Structure Medical, LLC.	Naples, FL, United States	Contract manufacturer	0		0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Structure Medical, LLC.	Mooresville, NC, United States	Contract manufacturer	0		0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0		0	api.fda.gov
Trimed, Inc.	Santa Clarita, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Tegra Medical	Hernando, MS, United States	Contract manufacturer	0		0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Contract manufacturer	0		0	api.fda.gov
Victoria Precision Inc.	Trevose, PA, United States	Contract manufacturer	0		0	api.fda.gov
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)	Parkrose, OR, United States	Contract manufacturer	0		0	api.fda.gov
Vorzeigen	Connersville, IN, United States	Contract manufacturer	0		0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
restor3d, inc.	Durham, NC, United States	Manufacturer	0		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.