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FDA 510(k)

Exactech® Novation® Element Press-fit Femoral Stem

K-Number: K153649 · 2016-08-31

ApplicantExactech, Inc.
Decision Date2016-08-31
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Novation® Element Press-fit Femoral Stem is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K153649. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech® Novation® Element Press-fit Femoral Stem?

Exactech® Novation® Element Press-fit Femoral Stem is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is Exactech, Inc.. The 510(k) number is K153649.

When did Exactech® Novation® Element Press-fit Femoral Stem receive FDA 510(k) clearance?

Exactech® Novation® Element Press-fit Femoral Stem received FDA 510(k) clearance on 2016-08-31, under 510(k) number K153649.

Who is the listed applicant for Exactech® Novation® Element Press-fit Femoral Stem?

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 Exactech® Novation® Element Press-fit Femoral Stem?

The FDA product code for Exactech® Novation® Element Press-fit Femoral Stem is MEH.

Related Clinical Trials

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Other records listing Exactech, Inc. as applicant

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Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, 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.

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