EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER— 510(k) K093275

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K093275 for EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER, Substantially Equivalent on 2010-05-27. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2009-10-19
Decision date: 2010-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, 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.