TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws— 510(k) K182346

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K182346 for TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws, Substantially Equivalent on 2018-11-26. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2018-08-28
Decision date: 2018-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.