Global Shoulder and Delta CTA systems— 510(k) K203230

Substantially Equivalent

Depuy Lnc.

FDA 510(k) clearance K203230 for Global Shoulder and Delta CTA systems, Substantially Equivalent on 2021-04-02. Applicant: Depuy Lnc..

Clearance details

Applicant: Depuy Lnc.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2020-11-02
Decision date: 2021-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, 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.