INTERMEDICS APR(TM) II FEMORAL COMPONENT— 510(k) K890450

Name: FDA 510(k) clearance K890450
Creator: U.S. Food and Drug Administration
Published: 1989-08-09

Substantially Equivalent for Some Indications

Intermedics Orthopedics

FDA 510(k) clearance K890450 for INTERMEDICS APR(TM) II FEMORAL COMPONENT, Substantially Equivalent for Some Indications on 1989-08-09. Applicant: Intermedics Orthopedics. Device class: 2.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code JDJ
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1989-01-30
Decision date: 1989-08-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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