Summit DuoFix HA Coating
K-Number: K193398 · 2020-02-04
ApplicantDePuy Orthopaedics, Inc.
Decision Date2020-02-04
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Summit DuoFix HA Coating is a medical device manufactured by DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2020-02-04 under approval number K193398. 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 Summit DuoFix HA Coating?
Summit DuoFix HA Coating is a medical device that received FDA 510(k) clearance on 2020-02-04. It is manufactured by DePuy Orthopaedics, Inc.. The 510(k) number is K193398.
When was Summit DuoFix HA Coating approved by the FDA?
Summit DuoFix HA Coating received FDA 510(k) clearance on 2020-02-04, under approval number K193398.
What company makes Summit DuoFix HA Coating?
Summit DuoFix HA Coating is manufactured by DePuy Orthopaedics, Inc..
What is the FDA product code for Summit DuoFix HA Coating?
The FDA product code for Summit DuoFix HA Coating is MEH.
Other Devices by DePuy Orthopaedics, Inc.
Related Devices (Code: MEH)
K153649Exactech® Novation® Element Press-fit Femoral StemExactech, Inc.
K160011H-Max S stemLima Corporate S.P.A.
K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.
K160907DePuy Actis DuoFix Hip ProsthesisDepuy(Ireland)
K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular LinerSignature Orthopaedics Pty, Ltd.
K153772Corin TriFit TS HipCorin U.S.A. Limited
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.