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FDA 510(k)

AMIStem-P Short Neck

K-Number: K192126 · 2019-11-22

ApplicantMedacta International S.A.
Decision Date2019-11-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMIStem-P Short Neck 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 2019-11-22 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K192126.

When did AMIStem-P Short Neck receive FDA 510(k) clearance?

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

Who is the listed applicant for AMIStem-P Short Neck?

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 AMIStem-P Short Neck?

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

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