SEATTLE II TOTAL HIP SYSTEM— 510(k) K812669

Substantially Equivalent

Hexcel Medical

FDA 510(k) clearance K812669 for SEATTLE II TOTAL HIP SYSTEM, Substantially Equivalent on 1981-10-02. Applicant: Hexcel Medical.

Clearance details

Applicant: Hexcel Medical
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1981-09-21
Decision date: 1981-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.