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FDA 510(k)

Exactech Vantage Total Ankle System

K-Number: K152217 · 2016-03-10

ApplicantExactech, Inc.
Decision Date2016-03-10
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Vantage Total Ankle System is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2016-03-10 under approval number K152217. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech Vantage Total Ankle System?

Exactech Vantage Total Ankle System is a medical device that received FDA 510(k) clearance on 2016-03-10. It is manufactured by Exactech, Inc.. The 510(k) number is K152217.

When was Exactech Vantage Total Ankle System approved by the FDA?

Exactech Vantage Total Ankle System received FDA 510(k) clearance on 2016-03-10, under approval number K152217.

What company makes Exactech Vantage Total Ankle System?

Exactech Vantage Total Ankle System is manufactured by Exactech, Inc..

What is the FDA product code for Exactech Vantage Total Ankle System?

The FDA product code for Exactech Vantage Total Ankle System is HSN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018) PMID: 28280294 Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices. Journal of health care finance (2016)

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 K153776Optetrak One Logic Femoral Components K171045Exactech® Truliant™ Line Extensions

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Related Devices (Code: HSN)

K153452Salto XT, Salto TalarisTornier S.A.S. K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc

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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