THEKEN LARGE CEMENT RESTRICTOR— 510(k) K012462

Unknown

Theken Surgical,Llc

FDA 510(k) clearance K012462 for THEKEN LARGE CEMENT RESTRICTOR, Unknown on 2001-10-29. 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: 2001-08-01
Decision date: 2001-10-29
Decision: Unknown
Clearance type: Traditional
Location: Barberton, OH, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.