GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00— 510(k) K043346

Substantially Equivalent

Genesis Medical LLC

FDA 510(k) clearance K043346 for GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00, Substantially Equivalent on 2005-01-31. Applicant: Genesis Medical LLC.

Clearance details

Applicant: Genesis Medical LLC
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2004-12-06
Decision date: 2005-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.