FDA 510(k)

Insignia Hip Stem

K-Number: K211703 · 2021-08-16

Decision Date2021-08-16

Product CodeMEH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Insignia Hip Stem is a medical device manufactured by Stryker Orthopaedics. It received FDA 510(k) clearance on 2021-08-16 under approval number K211703. 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 Insignia Hip Stem?

Insignia Hip Stem is a medical device that received FDA 510(k) clearance on 2021-08-16. It is manufactured by Stryker Orthopaedics. The 510(k) number is K211703.

When was Insignia Hip Stem approved by the FDA?

Insignia Hip Stem received FDA 510(k) clearance on 2021-08-16, under approval number K211703.

What company makes Insignia Hip Stem?

Insignia Hip Stem is manufactured by Stryker Orthopaedics.

What is the FDA product code for Insignia Hip Stem?

The FDA product code for Insignia Hip Stem is MEH.

Other Devices by Stryker Orthopaedics

K153345Stryker Orthopaedics Hip Systems Labeling Update K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads K173849Triathlon Total Knee System K191414EXETER Centralizer, EXETER 2.5mm Plug

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.