FDA 510(k)

Lateralized Glenosphere

K-Number: K193175 · 2020-08-11

Decision Date2020-08-11

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Lateralized Glenosphere is a medical device manufactured by Medacta Inernational SA. It received FDA 510(k) clearance on 2020-08-11 under approval number K193175. 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 Lateralized Glenosphere?

Lateralized Glenosphere is a medical device that received FDA 510(k) clearance on 2020-08-11. It is manufactured by Medacta Inernational SA. The 510(k) number is K193175.

When was Lateralized Glenosphere approved by the FDA?

Lateralized Glenosphere received FDA 510(k) clearance on 2020-08-11, under approval number K193175.

What company makes Lateralized Glenosphere?

Lateralized Glenosphere is manufactured by Medacta Inernational SA.

What is the FDA product code for Lateralized Glenosphere?

The FDA product code for Lateralized Glenosphere is PHX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.