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FDA 510(k)

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem

K-Number: K220731 · 2022-08-11

ApplicantStryker
Decision Date2022-08-11
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2022-08-11 under approval number K220731. 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, Restoration Modular 115mm Conical Distal Stem?

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem is a medical device that received FDA 510(k) clearance on 2022-08-11. It is manufactured by Stryker. The 510(k) number is K220731.

When was Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem approved by the FDA?

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem received FDA 510(k) clearance on 2022-08-11, under approval number K220731.

What company makes Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem?

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem is manufactured by Stryker.

What is the FDA product code for Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem?

The FDA product code for Insignia Hip Stem, Restoration Modular 115mm Conical Distal 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.

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