Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw— 510(k) K162325

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K162325 for Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw, Substantially Equivalent on 2017-03-06. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2016-08-19
Decision date: 2017-03-06
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.