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FDA 510(k)

MyShoulder Placement Guides

K-Number: K190738 · 2019-12-13

ApplicantMedacta International S.A.
Decision Date2019-12-13
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MyShoulder Placement Guides is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2019-12-13 under approval number K190738. 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 MyShoulder Placement Guides?

MyShoulder Placement Guides is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Medacta International S.A.. The 510(k) number is K190738.

When was MyShoulder Placement Guides approved by the FDA?

MyShoulder Placement Guides received FDA 510(k) clearance on 2019-12-13, under approval number K190738.

What company makes MyShoulder Placement Guides?

MyShoulder Placement Guides is manufactured by Medacta International S.A..

What is the FDA product code for MyShoulder Placement Guides?

The FDA product code for MyShoulder Placement Guides is PHX.

Related Clinical Trials

NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING

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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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