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FDA 510(k)

Restoration Modular 115mm Conical Distal Stem

K-Number: K213129 · 2021-12-21

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision Date2021-12-21
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Restoration Modular 115mm Conical Distal Stem is a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2021-12-21 under approval number K213129. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Restoration Modular 115mm Conical Distal Stem?

Restoration Modular 115mm Conical Distal Stem is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K213129.

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

Restoration Modular 115mm Conical Distal Stem received FDA 510(k) clearance on 2021-12-21, under approval number K213129.

What company makes Restoration Modular 115mm Conical Distal Stem?

Restoration Modular 115mm Conical Distal Stem is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

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

The FDA product code for Restoration Modular 115mm Conical Distal Stem is LZO.

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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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