ORTHOMET TITANIUM HYBRID FEMORAL STEM— 510(k) K945783

Substantially Equivalent

Orthomet, Inc.

FDA 510(k) clearance K945783 for ORTHOMET TITANIUM HYBRID FEMORAL STEM, Substantially Equivalent on 1995-05-30. Applicant: Orthomet, Inc..

Clearance details

Applicant: Orthomet, Inc.
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1994-11-25
Decision date: 1995-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.