TITANIUM CEMENT RESTRICTOR MATERIAL PEEK— 510(k) K010528

Name: FDA 510(k) clearance K010528
Creator: U.S. Food and Drug Administration
Published: 2001-10-10

Unknown

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K010528 for TITANIUM CEMENT RESTRICTOR MATERIAL PEEK, Unknown on 2001-10-10. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code JDK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2001-02-23
Decision date: 2001-10-10
Decision: Unknown
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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