EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE— 510(k) K121067

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K121067 for EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE, Substantially Equivalent on 2012-12-06. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2012-04-06
Decision date: 2012-12-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, US

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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.