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

Name: FDA 510(k) clearance K182346
Creator: U.S. Food and Drug Administration
Published: 2018-11-26

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.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Product code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2018-08-28
Decision date: 2018-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)2026-03-09

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K243448 — Equinoxe® Shoulder System2025-08-01
K243275 — Equinoxe® Scapula Fracture System2025-06-26
K243839 — Alteon® HA Femoral Stems2025-03-10

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.