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FDA 510(k)

Encore Hip Stem

K-Number: K211505 · 2021-09-24

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2021-09-24
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Encore Hip Stem is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2021-09-24 under approval number K211505. 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 Encore Hip Stem?

Encore Hip Stem is a medical device that received FDA 510(k) clearance on 2021-09-24. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K211505.

When was Encore Hip Stem approved by the FDA?

Encore Hip Stem received FDA 510(k) clearance on 2021-09-24, under approval number K211505.

What company makes Encore Hip Stem?

Encore Hip Stem is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Encore Hip Stem?

The FDA product code for Encore Hip Stem is MEH.

Other Devices by Signature Orthopaedics Pty, Ltd.

K160159Active-X Total Knee System K161155Origin Coxa Vara Hip Stem K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner K172019Brisbane ALIF Device, Gladstone ALIF Device K172020Arlington PLIF/TLIF Cage K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System

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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.

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