K092900

Substantially Equivalent

EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM

Applicant: Exactech, Inc.
Product code: PHX
Advisory panel: Orthopedic
Date received: 2009-09-21
Decision date: 2010-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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.