HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM— 510(k) K925536

Substantially Equivalent for Some Indications

Orthomet, Inc.

FDA 510(k) clearance K925536 for HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM, Substantially Equivalent for Some Indications on 1994-01-07. Applicant: Orthomet, Inc..

Clearance details

Applicant: Orthomet, Inc.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 1992-11-02
Decision date: 1994-01-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.