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FDA 510(k)

Shoulder System - TiNbN Coating

K-Number: K203755 · 2021-03-02

ApplicantMedacta International S.A.
Decision Date2021-03-02
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shoulder System - TiNbN Coating 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 2021-03-02 under 510(k) number K203755. 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 Shoulder System - TiNbN Coating?

Shoulder System - TiNbN Coating is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Medacta International S.A.. The 510(k) number is K203755.

When did Shoulder System - TiNbN Coating receive FDA 510(k) clearance?

Shoulder System - TiNbN Coating received FDA 510(k) clearance on 2021-03-02, under 510(k) number K203755.

Who is the listed applicant for Shoulder System - TiNbN Coating?

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 Shoulder System - TiNbN Coating?

The FDA product code for Shoulder System - TiNbN Coating 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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