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FDA 510(k)

Medacta Shoulder System

K-Number: K192967 · 2020-03-25

ApplicantMedacta International S.A.
Decision Date2020-03-25
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medacta Shoulder 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 2020-03-25 under 510(k) number K192967. 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 Medacta Shoulder System?

Medacta Shoulder System is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Medacta International S.A.. The 510(k) number is K192967.

When did Medacta Shoulder System receive FDA 510(k) clearance?

Medacta Shoulder System received FDA 510(k) clearance on 2020-03-25, under 510(k) number K192967.

Who is the listed applicant for Medacta Shoulder 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 Medacta Shoulder System?

The FDA product code for Medacta Shoulder System is PHX.

Other records listing Medacta International S.A. as applicant

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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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