DEPUT DELTA XTEND REVERSE SHOULDER— 510(k) K120174

Substantially Equivalent

Depuy France

FDA 510(k) clearance K120174 for DEPUT DELTA XTEND REVERSE SHOULDER, Substantially Equivalent on 2012-06-11. Applicant: Depuy France.

Clearance details

Applicant: Depuy France
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2012-01-20
Decision date: 2012-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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.