SYNATOMIC VARIABLE FIT TIBIAL PLATEAU— 510(k) K851341

Name: FDA 510(k) clearance K851341
Creator: U.S. Food and Drug Administration
Published: 1985-07-15

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K851341 for SYNATOMIC VARIABLE FIT TIBIAL PLATEAU, Substantially Equivalent on 1985-07-15. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Code KYK
Device class: Class 2
Regulation: 21 CFR 888.3500
Advisory panel: Orthopedic
Date received: 1985-04-03
Decision date: 1985-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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