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FDA 510(k)

M-Vizion Monobloc

K-Number: K212327 · 2022-05-24

ApplicantMedacta International S.A.
Decision Date2022-05-24
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M-Vizion Monobloc 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 2022-05-24 under 510(k) number K212327. 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 M-Vizion Monobloc?

M-Vizion Monobloc is a medical device that received FDA 510(k) clearance on 2022-05-24. The listed applicant is Medacta International S.A.. The 510(k) number is K212327.

When did M-Vizion Monobloc receive FDA 510(k) clearance?

M-Vizion Monobloc received FDA 510(k) clearance on 2022-05-24, under 510(k) number K212327.

Who is the listed applicant for M-Vizion Monobloc?

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 M-Vizion Monobloc?

The FDA product code for M-Vizion Monobloc 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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