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Data / Medical devices / Orthosis, Lumbo-Sacral / United States

FDA-registered makers of Orthosis, Lumbo-Sacral in the United States: 59 establishments

59 establishments in the United States are registered with the FDA to make Orthosis, Lumbo-Sacral (product code IPY). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Orthosis, Lumbo-Sacral
Product code
IPY
Country
United States

Makers of Orthosis, Lumbo-Sacral in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Alimed, LLCDedham, MA, United StatesManufacturer0000api.fda.gov
American Medical Products LLCEatontown, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Anthros Office, LLC (dba Anthros)Waukesha, WI, United StatesSpecification developer0000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesSpecification developer0000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer0000api.fda.gov
Becker Orthopedic Appliance Co.Troy, MI, United StatesManufacturer0000api.fda.gov
Bird & Cronin, LLCEagan, MN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Braceability, Inc.Cedar Falls, IA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
BSN medical Inc.Charlotte, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bauerfeind USA, INC.Atlanta, GA, United StatesSpecification developer0000api.fda.gov
BioSkin LLCAshland, OR, United StatesManufacturer0000api.fda.gov
Darco International, Inc.Huntington, WV, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Elastic Therapy, LLCAsheboro, NC, United StatesSpecification developer0000api.fda.gov
Ergoactives, LLCMiami, FL, United StatesSpecification developer0000api.fda.gov
Excite Medical Of Tampa Bay LLCTampa, FL, United StatesSpecification developer0000api.fda.gov
Electrostim Medical Services, Inc.Tampa, FL, United StatesSpecification developer0000api.fda.gov
Ferris MFG. Corp.Fort Worth, TX, United StatesManufacturer0000api.fda.gov
G-Force BracesManchester, NH, United StatesSpecification developer0000api.fda.gov
Green Sun MedicalSan Rafael, CA, United StatesManufacturer0000api.fda.gov
Greenwood Marketing LLCBrandenburg, KY, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Hely & WeberDfw, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
L&R Usa Inc.Milwaukee, WI, United StatesSpecification developer0000api.fda.gov
La Pointique International Ltd.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Manamed LLCDenton, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Medical Specialties, Inc.Wadesboro, NC, United StatesManufacturer0000api.fda.gov
Mobility Braces, LLCNorth Salt Lake, UT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Motion TherapeuticsFolsom, CA, United StatesManufacturer0000api.fda.gov
Mpusa, LLCPurchase, NY, United StatesSpecification developer0000api.fda.gov
Mueller Sports Medicine, Inc.Prairie Du Sac, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
NYOrthoBrooklyn, NY, United StatesManufacturer0000api.fda.gov
Oppo Medical, Inc.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Optec Usa, Inc.Lawrenceville, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Orthocor Medical Inc.Blaine, MN, United StatesManufacturer0000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesSpecification developer0000api.fda.gov
Orthomerica Products, Inc.Orlando, FL, United StatesManufacturer0000api.fda.gov
Otto Bock Healthcare LPSalt Lake City, UT, United StatesSpecification developer0000api.fda.gov
P.C.P. ChampionRipley, OH, United StatesManufacturer0000api.fda.gov
Performance Health Supply, LLC.Cedarburg, WI, United StatesManufacturer0000api.fda.gov
Portland Garment FactoryPortland, OR, United StatesContract manufacturer0000api.fda.gov
Preferred Industries, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pro-Tech InternationalRaynham, MA, United StatesManufacturer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Precision Medical ProductsRocklin, CA, United StatesSpecification developer0000api.fda.gov
Restorative Care Of America, Inc.Saint Petersburg, FL, United StatesManufacturer0000api.fda.gov
Spinal Technology, LLCWest Yarmouth, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Spio Inc.Burien, WA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Surgical Appliance Industries, Inc.Cincinnati, OH, United StatesManufacturer0000api.fda.gov
Spinal Systems, LLCLouisville, KY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Tiburon Medical EnterprisesSan Jacinto, CA, United StatesManufacturer0000api.fda.gov
Top Shelf Manufacturing, LLCTracy, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Trend Medical, LLCBethlehem, PA, United StatesSpecification developer0000api.fda.gov
Trulife, Inc.Bellingham, WA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Thuasne, LLCBakersfield, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
U.S. Orthotics, Inc.Tampa, FL, United StatesManufacturer0000api.fda.gov
VQ OrthocareVista, CA, United StatesSpecification developer0000api.fda.gov
Xenco Medical LLCSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.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.