Data / Medical devices / Appliance, Fixation, Spinal Intervertebral Body

Appliance, Fixation, Spinal Intervertebral Body (KWQ): 314 FDA-registered makers in 17 countries

314 establishments in 17 countries are registered with the FDA to make Appliance, Fixation, Spinal Intervertebral Body (product code KWQ, Class 2, 21 CFR 888.3060). 118 of them have a 510(k) clearance or PMA approval on file and 15 have a recall event. The FDA has issued 668 510(k) clearances under this code, the latest on September 24, 2026, and lists 50 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

KWQ

Device class

2

Regulation

888.3060

Medical specialty

Orthopedic

Implant

Yes

Makers by country

Makers of Appliance, Fixation, Spinal Intervertebral Body

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 September 24, 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.