Data / Medical devices / Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis / United States

FDA-registered makers of Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis in the United States: 112 establishments

Name: FDA-registered makers of Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

112 establishments in the United States are registered with the FDA to make Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (product code OSH). 11 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in the United States Watch these makers

Device: Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Product code: OSH
Country: United States

Makers of Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
K2M, Inc.	Leesburg, VA, United States	Manufacturer, Specification developer	6	August 30, 2013	0	api.fda.gov
ARCH Medical Solutions - Escondido LLC	Escondido, CA, United States	Manufacturer	1	April 8, 2016	0	api.fda.gov
Astura Medical	Irving, TX, United States	Complaint file establishment, Specification developer	1	April 8, 2016	0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	1	September 12, 2013	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	1	May 13, 2013	0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	1	September 4, 2013	0	api.fda.gov
JMG Machine, Inc.	La Mirada, CA, United States	Contract manufacturer, Manufacturer	1	April 16, 2012	0	api.fda.gov
Medtronic Puerto Rico Operations Co., Humacao	Humacao, PR, United States	Manufacturer	1	June 5, 2013	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	1	June 5, 2013	0	api.fda.gov
Orthopediatrics, Corp	Warsaw, IN, United States	Complaint file establishment, Repackager or relabeler, Specification developer	1	May 8, 2013	1	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer	1	June 5, 2013	0	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
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer, Specification developer	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 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
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
Alphatec Spine, Inc.	Memphis, TN, United States	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
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
Cep Bio-Coat, LLC	Farmington Hills, MI, 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
Depuy Orthopaedics	Bridgewater, MA, United States	Manufacturer, Repackager or relabeler	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
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
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Harwood Design, Inc.	Bristol, PA, United States	Contract 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
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Life Spine	Huntley, IL, United States	Specification developer	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
Medtech LLC	Millington, TN, United States	Contract manufacturer	0		0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Micro Precision Swiss	Santa Ana, CA, 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
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
Nexxt Spine LLC	Noblesville, IN, United States	Complaint file establishment, Manufacturer	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
Nuvasive, Inc.	San Diego, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	api.fda.gov
Orthofix Us LLC	Lewisville, TX, United States	Complaint file establishment, Manufacturer, 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
Paragon Medical, Inc.	Pierceton, IN, 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
Pulse Technologies, Inc.	Quakertown, PA, 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 Spine, Inc.	Pearl, MS, United States	Manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, 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
Seaspine Orthopedics Corporation	Carlsbad, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Spinal Elements, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Spinecraft LLC	Westmont, IL, United States	Manufacturer, Specification developer	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
Stryker Spine	Allendale, NJ, United States	Complaint file establishment, Manufacturer, Specification developer	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
Structure Medical, LLC.	Mooresville, NC, United States	Contract manufacturer	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
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
Turner Medical Inc.	Athens, AL, 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
Victoria Precision Inc.	Trevose, PA, United States	Contract manufacturer	0		0	api.fda.gov
Westwood Precision LLC	Allentown, PA, 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.