FDA 510(k)

MyShoulder Placement Guides

K-Number: K190738 · 2019-12-13

Decision Date2019-12-13

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MyShoulder Placement Guides 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 2019-12-13 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K190738.

When did MyShoulder Placement Guides receive FDA 510(k) clearance?

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

Who is the listed applicant for MyShoulder Placement Guides?

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 MyShoulder Placement Guides?

The FDA product code for MyShoulder Placement Guides is PHX.

Other records listing Medacta International S.A. as applicant

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.

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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.