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FDA 510(k)

World Hip Stem, World Cup, World Liner

K-Number: K201278 · 2020-09-21

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2020-09-21
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

World Hip Stem, World Cup, World Liner is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2020-09-21 under approval number K201278. 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 World Hip Stem, World Cup, World Liner?

World Hip Stem, World Cup, World Liner is a medical device that received FDA 510(k) clearance on 2020-09-21. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K201278.

When was World Hip Stem, World Cup, World Liner approved by the FDA?

World Hip Stem, World Cup, World Liner received FDA 510(k) clearance on 2020-09-21, under approval number K201278.

What company makes World Hip Stem, World Cup, World Liner?

World Hip Stem, World Cup, World Liner is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for World Hip Stem, World Cup, World Liner?

The FDA product code for World Hip Stem, World Cup, World Liner is MEH.

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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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