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 a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2016-08-31 under approval 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. It is manufactured by Exactech, Inc.. The 510(k) number is K153649.
When was Exactech® Novation® Element Press-fit Femoral Stem approved by the FDA?
Exactech® Novation® Element Press-fit Femoral Stem received FDA 510(k) clearance on 2016-08-31, under approval number K153649.
What company makes Exactech® Novation® Element Press-fit Femoral Stem?
Exactech® Novation® Element Press-fit Femoral Stem is manufactured by Exactech, Inc..
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.
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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.