OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS— 510(k) K925883

Name: FDA 510(k) clearance K925883
Creator: U.S. Food and Drug Administration
Published: 1993-06-15

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K925883 for OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS, Substantially Equivalent on 1993-06-15. Applicant: Osteonics Corp.. Device class: 2.

Clearance details

Applicant: Osteonics Corp.
Product code: Code JDJ
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1992-11-19
Decision date: 1993-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.