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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 a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2020-03-25 under approval 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. It is manufactured by Medacta International S.A.. The 510(k) number is K192967.

When was Medacta Shoulder System approved by the FDA?

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

What company makes Medacta Shoulder System?

Medacta Shoulder System is manufactured by Medacta International S.A..

What is the FDA product code for Medacta Shoulder System?

The FDA product code for Medacta Shoulder System is PHX.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING

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.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.

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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