United 36mm Ceramic Femoral Head, Delta

by United Orthopedic Corporation

510(k) K112463

Listed No authorization on record

Valid until

Not applicable

No authorization on record

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 7 Oct 2026. What this means

Specification

510(k)

510(k) Number: K112463
FDA Product Code: LZO

Device Class: Class II
Regulation: 21 CFR Part 888.3353
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

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