FEMORAL HEMI-HIP PROSTHESES— 510(k) K855228

Substantially Equivalent

Orthopaedic Device Corp.

FDA 510(k) clearance K855228 for FEMORAL HEMI-HIP PROSTHESES, Substantially Equivalent on 1986-02-11. Applicant: Orthopaedic Device Corp..

Clearance details

Applicant: Orthopaedic Device Corp.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1985-12-30
Decision date: 1986-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, 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.