EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...— 510(k) K110708

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K110708 for EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES..., Substantially Equivalent on 2011-04-01. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2011-03-14
Decision date: 2011-04-01
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.