Data / Medical devices / Orthosis, Lumbo-Sacral

Orthosis, Lumbo-Sacral (IPY): 151 FDA-registered makers in 25 countries

151 establishments in 25 countries are registered with the FDA to make Orthosis, Lumbo-Sacral (product code IPY, Class 1, 21 CFR 890.3490). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on January 17, 1983, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code

IPY

Device class

1

Regulation

890.3490

Medical specialty

Physical Medicine

Makers by country

Makers of Orthosis, Lumbo-Sacral

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated January 17, 1983. 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.