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

Name: FDA 510(k) clearance K051642
Creator: U.S. Food and Drug Administration
Published: 2005-08-22

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. Device class: 2.

Clearance details

Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
Product code: Code NDF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2005-06-20
Decision date: 2005-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prior Lake, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K051642

K-number listed on FDA's recall record

Z-1595-2026 — FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.Class II·Ongoing·I.T.S. GmbH·20260123

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051642.

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