MODIFICATION TO FORTITUDE CEMENT RESTRICTOR— 510(k) K031837

Name: FDA 510(k) clearance K031837
Creator: U.S. Food and Drug Administration
Published: 2003-07-24

Substantially Equivalent

Spinal Concepts, Inc.

FDA 510(k) clearance K031837 for MODIFICATION TO FORTITUDE CEMENT RESTRICTOR, Substantially Equivalent on 2003-07-24. Applicant: Spinal Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Spinal Concepts, Inc.
Product code: Code JDK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2003-06-16
Decision date: 2003-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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