OSTEONICS(R) MID-SHAFT CEMENT SPACER— 510(k) K910461

Name: FDA 510(k) clearance K910461
Creator: U.S. Food and Drug Administration
Published: 1991-04-08

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K910461 for OSTEONICS(R) MID-SHAFT CEMENT SPACER, Substantially Equivalent on 1991-04-08. Applicant: Osteonics Corp.. Device class: 2.

Clearance details

Applicant: Osteonics Corp.
Product code: Code JDK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1991-02-04
Decision date: 1991-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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