Data / Medical devices / Fastener, Fixation, Nondegradable, Soft Tissue

Fastener, Fixation, Nondegradable, Soft Tissue (MBI): 171 FDA-registered makers in 21 countries

171 establishments in 21 countries are registered with the FDA to make Fastener, Fixation, Nondegradable, Soft Tissue (product code MBI, Class 2, 21 CFR 888.3040). 91 of them have a 510(k) clearance or PMA approval on file and 17 have a recall event. The FDA has issued 606 510(k) clearances under this code, the latest on October 23, 2026, and lists 48 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

MBI

Device class

2

Regulation

888.3040

Medical specialty

Orthopedic

Implant

Yes

Makers by country

Makers of Fastener, Fixation, Nondegradable, Soft Tissue

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 23, 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.