OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T— 510(k) K093360

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K093360 for OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T, Substantially Equivalent on 2010-01-11. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2009-10-28
Decision date: 2010-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.