TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT— 510(k) K924050

Substantially Equivalent

Orthomet, Inc.

FDA 510(k) clearance K924050 for TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT, Substantially Equivalent on 1993-08-25. Applicant: Orthomet, Inc..

Clearance details

Applicant: Orthomet, Inc.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1992-08-05
Decision date: 1993-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.