FDA 510(k)

AMIStem-P Short Neck

K-Number: K192126 · 2019-11-22

Decision Date2019-11-22

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AMIStem-P Short Neck is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2019-11-22 under approval number K192126. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIStem-P Short Neck?

AMIStem-P Short Neck is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Medacta International S.A.. The 510(k) number is K192126.

When was AMIStem-P Short Neck approved by the FDA?

AMIStem-P Short Neck received FDA 510(k) clearance on 2019-11-22, under approval number K192126.

What company makes AMIStem-P Short Neck?

AMIStem-P Short Neck is manufactured by Medacta International S.A..

What is the FDA product code for AMIStem-P Short Neck?

The FDA product code for AMIStem-P Short Neck is LZO.

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Related Devices (Code: LZO)

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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.