EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.— 510(k) K093430

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K093430 for EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD., Substantially Equivalent on 2010-09-02. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2009-11-03
Decision date: 2010-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.