FR.O.H. CALCANEUS REPAIR SYSTEM— 510(k) K051642

Substantially Equivalent

I.T.S. Implantat-Technologie-Systeme GmbH

FDA 510(k) clearance K051642 for FR.O.H. CALCANEUS REPAIR SYSTEM, Substantially Equivalent on 2005-08-22. Applicant: I.T.S. Implantat-Technologie-Systeme GmbH.

Clearance details

Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
Product code: Code NDF
Advisory panel: Orthopedic
Date received: 2005-06-20
Decision date: 2005-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prior Lake, MN, US

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