THEKEN SMALL CEMENT RESTRICTOR— 510(k) K012278

Unknown

Theken Surgical,Llc

FDA 510(k) clearance K012278 for THEKEN SMALL CEMENT RESTRICTOR, Unknown on 2001-10-17. Applicant: Theken Surgical,Llc. Device class: 2.

Clearance details

Applicant: Theken Surgical,Llc
Product code: Code JDK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2001-07-19
Decision date: 2001-10-17
Decision: Unknown
Clearance type: Traditional
Location: Barberton, OH, 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.