CADENCE PEEK CEMEENT RESTRICTOR— 510(k) K023647

Name: FDA 510(k) clearance K023647
Creator: U.S. Food and Drug Administration
Published: 2002-11-27

Substantially Equivalent

Spinal Concepts, Inc.

FDA 510(k) clearance K023647 for CADENCE PEEK CEMEENT RESTRICTOR, Substantially Equivalent on 2002-11-27. 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: 2002-10-30
Decision date: 2002-11-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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