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FDA 510(k)

SMS Cementless Stem

K-Number: K203041 · 2020-12-02

ApplicantMedacta International S.A.
Decision Date2020-12-02
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMS Cementless Stem is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2020-12-02 under approval number K203041. 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 SMS Cementless Stem?

SMS Cementless Stem is a medical device that received FDA 510(k) clearance on 2020-12-02. It is manufactured by Medacta International S.A.. The 510(k) number is K203041.

When was SMS Cementless Stem approved by the FDA?

SMS Cementless Stem received FDA 510(k) clearance on 2020-12-02, under approval number K203041.

What company makes SMS Cementless Stem?

SMS Cementless Stem is manufactured by Medacta International S.A..

What is the FDA product code for SMS Cementless Stem?

The FDA product code for SMS Cementless Stem is LZO.

Other Devices by Medacta International S.A.

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Related Devices (Code: 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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