Data / Medical devices / Joint, Knee, External Limb Component

Joint, Knee, External Limb Component (ISY): 55 FDA-registered makers in 17 countries

55 establishments in 17 countries are registered with the FDA to make Joint, Knee, External Limb Component (product code ISY, Class 1, 21 CFR 890.3420). 0 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on October 13, 2010, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

ISY

Device class

1

Regulation

890.3420

Medical specialty

Physical Medicine

Makers by country

Makers of Joint, Knee, External Limb Component

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 October 13, 2010. 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.