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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 the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2018-11-26 under 510(k) 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. The listed applicant is Exactech, Inc.. The 510(k) number is K182346.

When did TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws receive FDA 510(k) clearance?

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

Who is the listed applicant for TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws?

The FDA 510(k) record lists Exactech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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.

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