Data / Medical devices / Orthopedic Manual Surgical Instrument

Orthopedic Manual Surgical Instrument (LXH): 947 FDA-registered makers in 32 countries

947 establishments in 32 countries are registered with the FDA to make Orthopedic Manual Surgical Instrument (product code LXH, Class 1, 21 CFR 888.4540). 11 of them have a 510(k) clearance or PMA approval on file and 48 have a recall event. The FDA has issued 58 510(k) clearances under this code, the latest on December 20, 2019, and lists 267 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

LXH

Device class

1

Regulation

888.4540

Medical specialty

Orthopedic

Makers by country

Makers of Orthopedic Manual Surgical Instrument

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 December 20, 2019. 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.