OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM— 510(k) K953961

Name: FDA 510(k) clearance K953961
Creator: U.S. Food and Drug Administration
Published: 1995-11-29

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K953961 for OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM, Substantially Equivalent on 1995-11-29. Applicant: Osteonics Corp.. Device class: 1.

Clearance details

Applicant: Osteonics Corp.
Product code: Code FWW
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1995-08-22
Decision date: 1995-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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