Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws

K-Number: K182346 · 2018-11-26

ApplicantExactech, Inc.
Decision Date2018-11-26
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2018-11-26 under approval number K182346. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws?

TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws is a medical device that received FDA 510(k) clearance on 2018-11-26. It is manufactured by Exactech, Inc.. The 510(k) number is K182346.

When was TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws approved by the FDA?

TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws received FDA 510(k) clearance on 2018-11-26, under approval number K182346.

What company makes TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws?

TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws is manufactured by Exactech, Inc..

What is the FDA product code for TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws?

The FDA product code for TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws is MBH.

Related Clinical Trials

NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING

Other Devices by Exactech, Inc.

K153649Exactech® Novation® Element Press-fit Femoral Stem K160697Gibralt® Spine System and Gibralt® Occipital Spine System K153595Optetrak Logic Metaphyseal Cones K160484Optetrak Advanced Patella K152217Exactech Vantage Total Ankle System K153776Optetrak One Logic Femoral Components

View all 41 devices →

Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑