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FDA 510(k)

Glenoid Reconstruction System – Full Wedge Baseplate

K-Number: K231911 · 2023-11-09

ApplicantMedacta International S.A.
Decision Date2023-11-09
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Glenoid Reconstruction System – Full Wedge Baseplate is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2023-11-09 under approval number K231911. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Glenoid Reconstruction System – Full Wedge Baseplate?

Glenoid Reconstruction System – Full Wedge Baseplate is a medical device that received FDA 510(k) clearance on 2023-11-09. It is manufactured by Medacta International S.A.. The 510(k) number is K231911.

When was Glenoid Reconstruction System – Full Wedge Baseplate approved by the FDA?

Glenoid Reconstruction System – Full Wedge Baseplate received FDA 510(k) clearance on 2023-11-09, under approval number K231911.

What company makes Glenoid Reconstruction System – Full Wedge Baseplate?

Glenoid Reconstruction System – Full Wedge Baseplate is manufactured by Medacta International S.A..

What is the FDA product code for Glenoid Reconstruction System – Full Wedge Baseplate?

The FDA product code for Glenoid Reconstruction System – Full Wedge Baseplate is PHX.

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Related Devices (Code: PHX)

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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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