APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT— 510(k) K853524

Name: FDA 510(k) clearance K853524
Creator: U.S. Food and Drug Administration
Published: 1985-11-22

Substantially Equivalent for Some Indications

Intermedics Orthopedics

FDA 510(k) clearance K853524 for APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT, Substantially Equivalent for Some Indications on 1985-11-22. Applicant: Intermedics Orthopedics. Device class: 2.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code KMC
Device class: Class 2
Regulation: 21 CFR 888.3340
Advisory panel: Orthopedic
Date received: 1985-08-22
Decision date: 1985-11-22
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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