TOTAL SHOULDER SYSTEM— 510(k) K102670

Substantially Equivalent

Shoulder Innovations, LLC

FDA 510(k) clearance K102670 for TOTAL SHOULDER SYSTEM, Substantially Equivalent on 2011-01-24. Applicant: Shoulder Innovations, LLC.

Clearance details

Applicant: Shoulder Innovations, LLC
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2010-09-16
Decision date: 2011-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ada, MI, 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.