PROXIMAL CEMENT SPACER— 510(k) K895378

Name: FDA 510(k) clearance K895378
Creator: U.S. Food and Drug Administration
Published: 1989-11-22

Substantially Equivalent

Osteonics Reconstructive Products Div.

FDA 510(k) clearance K895378 for PROXIMAL CEMENT SPACER, Substantially Equivalent on 1989-11-22. Applicant: Osteonics Reconstructive Products Div.. Device class: 2.

Clearance details

Applicant: Osteonics Reconstructive Products Div.
Product code: Code JDK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1989-08-30
Decision date: 1989-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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