Delta Xtend Revers Shoulder System— 510(k) K192448

Substantially Equivalent

Depuy(Ireland)

FDA 510(k) clearance K192448 for Delta Xtend Revers Shoulder System, Substantially Equivalent on 2019-10-04. Applicant: Depuy(Ireland).

Clearance details

Applicant: Depuy(Ireland)
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2019-09-06
Decision date: 2019-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Cork, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

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.