ANITOMIC TOTAL HIP SYSTEM— 510(k) K800050

Substantially Equivalent

Hexcel Medical

FDA 510(k) clearance K800050 for ANITOMIC TOTAL HIP SYSTEM, Substantially Equivalent on 1980-01-24. Applicant: Hexcel Medical.

Clearance details

Applicant: Hexcel Medical
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1980-01-09
Decision date: 1980-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.