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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 a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-03-02 under approval 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. It is manufactured by Medacta International S.A.. The 510(k) number is K203755.

When was Shoulder System - TiNbN Coating approved by the FDA?

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

What company makes Shoulder System - TiNbN Coating?

Shoulder System - TiNbN Coating is manufactured by Medacta International S.A..

What is the FDA product code for Shoulder System - TiNbN Coating?

The FDA product code for Shoulder System - TiNbN Coating is PHX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Medacta International S.A.

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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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