Data / Medical devices / Rod, Fixation, Intramedullary And Accessories

Rod, Fixation, Intramedullary And Accessories (HSB): 232 FDA-registered makers in 22 countries

232 establishments in 22 countries are registered with the FDA to make Rod, Fixation, Intramedullary And Accessories (product code HSB, Class 2, 21 CFR 888.3020). 79 of them have a 510(k) clearance or PMA approval on file and 20 have a recall event. The FDA has issued 532 510(k) clearances under this code, the latest on October 19, 2026, and lists 116 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

HSB

Device class

2

Regulation

888.3020

Medical specialty

Orthopedic

Implant

Yes

Makers by country

Makers of Rod, Fixation, Intramedullary And Accessories

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 19, 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.