NOVASPINE CEMENT RESTRICTOR NSCR— 510(k) K051607

Name: FDA 510(k) clearance K051607
Creator: U.S. Food and Drug Administration
Published: 2005-10-07

Substantially Equivalent

Novaspine, LLC

FDA 510(k) clearance K051607 for NOVASPINE CEMENT RESTRICTOR NSCR, Substantially Equivalent on 2005-10-07. Applicant: Novaspine, LLC. Device class: 2.

Clearance details

Applicant: Novaspine, LLC
Product code: Code JDK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2005-06-17
Decision date: 2005-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmsford, NY, US

Download summary PDF View on FDA.gov ↗

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