Data / Medical devices / Bone Fixation Cerclage, Sublaminar

Bone Fixation Cerclage, Sublaminar (OWI): 58 FDA-registered makers in 5 countries

58 establishments in 5 countries are registered with the FDA to make Bone Fixation Cerclage, Sublaminar (product code OWI, Class 2, 21 CFR 888.3010). 18 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 37 510(k) clearances under this code, the latest on May 27, 2026, and lists 2 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code

OWI

Device class

2

Regulation

888.3010

Medical specialty

Orthopedic

Implant

Yes

Makers by country

Makers of Bone Fixation Cerclage, Sublaminar

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 May 27, 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.