Data / Medical devices / Orthosis, Cervical

Orthosis, Cervical (IQK): 267 FDA-registered makers in 28 countries

267 establishments in 28 countries are registered with the FDA to make Orthosis, Cervical (product code IQK, Class 1, 21 CFR 890.3490). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on July 22, 1993, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

IQK

Device class

1

Regulation

890.3490

Medical specialty

Physical Medicine

Makers by country

Makers of Orthosis, Cervical

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 July 22, 1993. 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.