OSS/(SCARF)- AND OSW-SCREW— 510(k) K042079

Substantially Equivalent

O.M.T. Oberflachen-Und Materialtechnologie GmbH

FDA 510(k) clearance K042079 for OSS/(SCARF)- AND OSW-SCREW, Substantially Equivalent on 2004-12-20. Applicant: O.M.T. Oberflachen-Und Materialtechnologie GmbH.

Clearance details

Applicant: O.M.T. Oberflachen-Und Materialtechnologie GmbH
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2004-08-02
Decision date: 2004-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington, WV, US

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.