Data / Medical devices / Orthosis, Spinal Pedicle Fixation / United States

FDA-registered makers of Orthosis, Spinal Pedicle Fixation in the United States: 194 establishments

Name: FDA-registered makers of Orthosis, Spinal Pedicle Fixation in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

194 establishments in the United States are registered with the FDA to make Orthosis, Spinal Pedicle Fixation (product code MNI). 35 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device: Orthosis, Spinal Pedicle Fixation
Product code: MNI
Country: United States

Makers of Orthosis, Spinal Pedicle Fixation in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	25	December 22, 2006	0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler	25	December 22, 2006	1	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	19	October 15, 2010	0	api.fda.gov
K2M, Inc.	Leesburg, VA, United States	Manufacturer, Specification developer	15	November 20, 2013	0	api.fda.gov
Medtronic Puerto Rico Operations Co., Humacao	Humacao, PR, United States	Manufacturer	15	December 22, 2006	0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	11	June 2, 2004	0	api.fda.gov
Spine Wave, Inc.	Shelton, CT, United States	Manufacturer, Specification developer	10	February 26, 2016	0	api.fda.gov
Depuy Orthopaedics	Bridgewater, MA, United States	Manufacturer, Repackager or relabeler	9	June 8, 2007	0	api.fda.gov
Precision Spine, Inc.	Pearl, MS, United States	Manufacturer	9	June 26, 2014	0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	8	February 1, 2012	2	api.fda.gov
Stryker Spine	Allendale, NJ, United States	Complaint file establishment, Manufacturer, Specification developer	7	February 14, 2008	2	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Complaint file establishment, Manufacturer, Specification developer	6	March 13, 2008	0	api.fda.gov
Choice Spine LLC	Knoxville, TN, United States	Complaint file establishment, Specification developer	5	July 15, 2011	0	api.fda.gov
Seaspine Orthopedics Corporation	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	5	March 27, 2009	0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	4	February 17, 2010	0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	4	February 17, 2010	0	api.fda.gov
Life Spine	Huntley, IL, United States	Specification developer	4	March 13, 2012	0	api.fda.gov
CAPTIVA SPINE, Inc.	Jupiter, FL, United States	Complaint file establishment, Specification developer	3	October 16, 2012	1	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer	3	June 5, 2001	0	api.fda.gov
Nexxt Spine LLC	Noblesville, IN, United States	Complaint file establishment, Manufacturer	2	October 10, 2013	0	api.fda.gov
Spinal Elements, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	2	February 2, 2011	0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	2	October 7, 2004	0	api.fda.gov
Zavation	Flowood, MS, United States	Complaint file establishment, Manufacturer, Specification developer	2	April 2, 2012	0	api.fda.gov
Altus Partners	West Chester, PA, United States	Specification developer	1	October 31, 2013	0	api.fda.gov
CTL Medical Corporation	Carrollton, TX, United States	Complaint file establishment, Manufacturer, Specification developer	1	August 20, 2013	1	api.fda.gov
Eminent Spine, LLC	Plano, TX, United States	Manufacturer	1	April 22, 2010	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	1	August 6, 2007	0	api.fda.gov
K7 LLC	Henderson, NV, United States	Manufacturer, Specification developer	1	January 27, 2014	0	api.fda.gov
Kyocera Medical Technologies, Inc.	Redlands, CA, United States	Complaint file establishment, Specification developer	1	December 7, 2010	0	api.fda.gov
Medtronic Xomed, Inc.	Jacksonville, FL, United States	Manufacturer	1	September 25, 2006	0	api.fda.gov
Mighty Oak Medical	Englewood, CO, United States	Complaint file establishment, Manufacturer	1	December 11, 2015	0	api.fda.gov
Nuvasive, Inc.	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	1	August 6, 2007	0	api.fda.gov
Orthopedic Sciences, Inc	Overland Park, KS, United States	Complaint file establishment, Specification developer	1	September 3, 2004	0	api.fda.gov
Vy Spine, LLC	Bountiful, UT, United States	Manufacturer, Specification developer	1	September 17, 2015	0	api.fda.gov
Xtant Medical Holdings, Inc.	Belgrade, MT, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	1	September 25, 2015	1	api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)	Riviera Beach, FL, United States	Contract manufacturer	0		0	api.fda.gov
Alden Tool Company, Inc.	Berlin, CT, United States	Contract manufacturer	0		0	api.fda.gov
American Manufacturing And Engineering	Montgomeryville, PA, United States	Contract manufacturer	0		0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
ARCH - Quakertown	Quakertown, PA, United States	Contract manufacturer	0		0	api.fda.gov
Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical Components	Huntingdon Valley, PA, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical & Aerospace - Woburn	Woburn, MA, 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 - Escondido LLC	Escondido, CA, United States	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 - Olive Branch	Olive Branch, MS, 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
Argon Medical Devices, Inc.	Wheeling, IL, United States	Contract manufacturer	0		0	api.fda.gov
Atlas Spine Inc.	Jupiter, FL, United States	Manufacturer	0		0	api.fda.gov
Autocam Medical	Plymouth, MA, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Integrated Medical Solutions, Inc	Mentor, OH, United States	Contract manufacturer	0		0	api.fda.gov
Axial Medical	Ivyland, PA, United States	Contract manufacturer	0		0	api.fda.gov
Acero Precision	West Chester, PA, United States	Contract manufacturer	0		0	api.fda.gov
Astura Medical	Irving, TX, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	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 & G MFG. Co.	Hatfield, PA, 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
Biomet, Inc.	Warsaw, IN, United States	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&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, United States	Contract manufacturer	0		0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Camber Spine Technologies	King of Prussia, PA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Cep Bio-Coat, LLC	Farmington Hills, MI, United States	Contract manufacturer	0		0	api.fda.gov
Classic Wire Cut Company, Inc.	Valencia, CA, United States	Contract manufacturer	0		0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0		0	api.fda.gov
Degen Medical	Florence, SC, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Deroyal Industries, Inc.	Powell, TN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	api.fda.gov
Elite Medical, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Elite Medical, LLC	Cordova, TN, 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
First Article Inc	Souderton, PA, United States	Contract manufacturer	0		0	api.fda.gov
Flex-Cell Precision, Inc.	Lancaster, PA, United States	Contract manufacturer	0		0	api.fda.gov
Flospine LLC	Boca Raton, FL, United States	Manufacturer	0		0	api.fda.gov
Fort Wayne Metals Research Products, LLC	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Ferry Machine Corporation	Little Ferry, NJ, United States	Contract manufacturer	0		0	api.fda.gov
G Surgical LLC	Austin, TX, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Gauthier Biomedical, Inc.	Grafton, WI, United States	Contract manufacturer	0		0	api.fda.gov
Genesys Spine	Austin, TX, United States	Manufacturer	0		0	api.fda.gov
Geotec, Inc.	Warwick, RI, United States	Contract manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer, Manufacturer for export	0		0	api.fda.gov
Guardian Medical Usa, Inc	Swanton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Hammill MFG. Co.	Maumee, OH, United States	Contract manufacturer	0		0	api.fda.gov
Harwood Design, Inc.	Bristol, PA, United States	Contract manufacturer	0		0	api.fda.gov
Hoosier, Inc.	Corona, CA, United States	Contract manufacturer	0		0	api.fda.gov
Himed, LLC	Old Bethpage, NY, United States	Contract manufacturer	0		0	api.fda.gov
INNO Holdings Inc.	Millcreek, UT, United States	Manufacturer	0		0	api.fda.gov
Insert Molding Solutions, Inc.	Cumming, GA, United States	Contract manufacturer	0		0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
J & J Precision Technologies, LLC	Lititz, PA, United States	Contract manufacturer	0		0	api.fda.gov
J&B Precision, Inc.	Cordova, TN, United States	Contract manufacturer	0		0	api.fda.gov
Jarvis Surgical Inc.	Westfield, MA, 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
Kalitec Direct LLC DBA Kalitec Medical	Sarasota, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Life Science Outsourcing, Inc.	Brea, CA, United States	Contract manufacturer	0		0	api.fda.gov
LISI MEDICAL REmmele	Big Lake, MN, United States	Contract manufacturer	0		0	api.fda.gov
LISI MEDICAL Remmele	Coon Rapids, MN, United States	Contract manufacturer	0		0	api.fda.gov
Lowell,inc.	Brooklyn Park, MN, United States	Contract manufacturer	0		0	api.fda.gov
Mackay Manufacturing, Inc.	Spokane Valley, WA, United States	Contract manufacturer	0		0	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	api.fda.gov
Medical Component Specialists	Bellingham, MA, United States	Contract manufacturer	0		0	api.fda.gov
Medical Modeling - A 3D Systems Company	Littleton, CO, United States	Contract manufacturer	0		0	api.fda.gov
Medtech LLC	Millington, TN, 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
Mirus, LLC	Marietta, GA, United States	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
Microcision LLC	Pennsauken, NJ, 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
Nexus Spine, L.L.C.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Nexus Spine, LLC.	Lehi, UT, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
NML Medical, LLC	West Carrollton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Nuvasive, Inc.	Guaynabo, PR, United States	Manufacturer	0		0	api.fda.gov
Oberg Medical Products Company	Sarver, PA, 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
Ortho Development Corp.	Draper, UT, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Osseus Fusion Systems LLC	Dallas, TX, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, 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
P&F Machining	Otsego, MN, United States	Manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Paramount Surgicals, Inc.	Brownsville, TX, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Perryman Company	Houston, PA, 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 Forms, Inc.	Butler, NJ, 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
Presidio Surgical, Inc.	New Braunfels, TX, United States	Manufacturer	0		0	api.fda.gov
Pro-Tech Design & MFG., Inc.	Santa Fe Springs, CA, United States	Contract manufacturer	0		0	api.fda.gov
Pulse Technologies, Inc.	Quakertown, PA, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, 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
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
Remington Medical, Inc.	Alpharetta, GA, United States	Contract manufacturer	0		0	api.fda.gov
Republic Spine	Fort Lauderdale, FL, United States	Complaint file establishment, 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
Romd, LLC	Rochester Hills, MI, United States	Manufacturer	0		0	api.fda.gov
Remington Medical, Inc.	Alpharetta, GA, United States	Contract manufacturer	0		0	api.fda.gov
Spinecraft LLC	Westmont, IL, United States	Manufacturer, Specification developer	0		0	api.fda.gov
SPINEFRONTIER, INC. DBA LESspine Innovations	Burlington, MA, United States	Manufacturer	0		3	api.fda.gov
Spineology Inc.	Saint Paul, MN, United States	Manufacturer	0		0	api.fda.gov
Stoll Metalcraft, Inc.	Santa Clarita, CA, 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
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0		0	api.fda.gov
SpineSmith Holdings, LLC	Austin, TX, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Structure Medical, LLC.	Mooresville, NC, United States	Contract manufacturer	0		0	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Summit Orthopedic Technologies Inc.	Naples, FL, 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
Teslake, Inc.	San Diego, CA, United States	Specification developer	0		0	api.fda.gov
TOMZ Corporation	Berlin, CT, United States	Contract manufacturer	0		0	api.fda.gov
Troy Innovative Instruments Co LLC	Middlefield, OH, United States	Contract manufacturer	0		0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	api.fda.gov
Turner Medical Inc.	Athens, AL, United States	Contract manufacturer	0		0	api.fda.gov
Tech Industries. Inc.	Cleveland, OH, United States	Contract manufacturer, Manufacturer for export	0		0	api.fda.gov
Tecomet, Inc.	Wilmington, MA, United States	Contract manufacturer	0		0	api.fda.gov
Tegra Medical	Hernando, MS, United States	Contract manufacturer	0		0	api.fda.gov
The E F PRECISION GROUP	Willow Grove, PA, United States	Contract manufacturer	0		0	api.fda.gov
Titan Spine, a Division of Medtronic	Milwaukee, WI, United States	Manufacturer	0		0	api.fda.gov
Unity Tool, Inc.	Osseo, MN, United States	Contract manufacturer	0		0	api.fda.gov
Unified Spine, LLC	Westerville, OH, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Victoria Precision Inc.	Trevose, PA, United States	Contract manufacturer	0		0	api.fda.gov
Viant AS&O Holdings, LLC	Orchard Park, NY, United States	Contract manufacturer	0		0	api.fda.gov
Westwood Precision LLC	Allentown, PA, United States	Contract manufacturer	0		0	api.fda.gov
Xenco Medical LLC	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract 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.