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FDA 510(k)

Glenoid Reconstruction System

K-Number: K213459 · 2022-11-23

ApplicantMedacta International S.A.
Decision Date2022-11-23
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Glenoid Reconstruction System 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 2022-11-23 under 510(k) number K213459. 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?

Glenoid Reconstruction System is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is Medacta International S.A.. The 510(k) number is K213459.

When did Glenoid Reconstruction System receive FDA 510(k) clearance?

Glenoid Reconstruction System received FDA 510(k) clearance on 2022-11-23, under 510(k) number K213459.

Who is the listed applicant for Glenoid Reconstruction System?

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?

The FDA product code for Glenoid Reconstruction System is PHX.

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Related Devices (Code: PHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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