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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 the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K231911.

When did Glenoid Reconstruction System – Full Wedge Baseplate receive FDA 510(k) clearance?

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

Who is the listed applicant for Glenoid Reconstruction System – Full Wedge Baseplate?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

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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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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