HUMERAL HEAD PLATE WITH ANGULAR STABILITY— 510(k) K051412

Substantially Equivalent

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

FDA 510(k) clearance K051412 for HUMERAL HEAD PLATE WITH ANGULAR STABILITY, Substantially Equivalent on 2005-07-11. Applicant: I.T.S. Implantat-Technologie-Systeme GmbH.

Clearance details

Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2005-05-31
Decision date: 2005-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prior Lake, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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