PT DISTAL TIP CEMENT SPACER— 510(k) K894708

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K894708 for PT DISTAL TIP CEMENT SPACER, Substantially Equivalent on 1989-10-10. 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: 1989-07-24
Decision date: 1989-10-10
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.