GLOBAL ICON Stemless Shoulder System— 510(k) K212683

Substantially Equivalent

Depuy(Ireland)

FDA 510(k) clearance K212683 for GLOBAL ICON Stemless Shoulder System, Substantially Equivalent on 2022-01-19. Applicant: Depuy(Ireland).

Clearance details

Applicant: Depuy(Ireland)
Product code: Code PKC
Advisory panel: Orthopedic
Date received: 2021-08-24
Decision date: 2022-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cork, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code PKC

product code PKC

Injury: 258
Total: 258

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.