SOLAR SHOULDER OFFSET HUMERAL HEAD— 510(k) K001419

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K001419 for SOLAR SHOULDER OFFSET HUMERAL HEAD, Substantially Equivalent on 2000-07-27. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2000-05-05
Decision date: 2000-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.