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FDA 510(k)

Amis K Long

K-Number: K220405 · 2022-04-12

ApplicantMedacta International S.A.
Decision Date2022-04-12
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Amis K Long 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 2022-04-12 under 510(k) number K220405. 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 Amis K Long?

Amis K Long is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Medacta International S.A.. The 510(k) number is K220405.

When did Amis K Long receive FDA 510(k) clearance?

Amis K Long received FDA 510(k) clearance on 2022-04-12, under 510(k) number K220405.

Who is the listed applicant for Amis K Long?

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 Amis K Long?

The FDA product code for Amis K Long 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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