DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING— 510(k) K130008

Substantially Equivalent

I.T.S. GmbH

FDA 510(k) clearance K130008 for DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING, Substantially Equivalent on 2013-06-25. Applicant: I.T.S. GmbH.

Clearance details

Applicant: I.T.S. GmbH
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2013-01-02
Decision date: 2013-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prior Lake, MN, US

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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.