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FDA 510(k)

M-Vizion Femoral Revision System

K-Number: K170690 · 2017-11-29

ApplicantMedacta International S.A.
Decision Date2017-11-29
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M-Vizion Femoral Revision System 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 2017-11-29 under 510(k) number K170690. 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 Femoral Revision System?

M-Vizion Femoral Revision System is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Medacta International S.A.. The 510(k) number is K170690.

When did M-Vizion Femoral Revision System receive FDA 510(k) clearance?

M-Vizion Femoral Revision System received FDA 510(k) clearance on 2017-11-29, under 510(k) number K170690.

Who is the listed applicant for M-Vizion Femoral Revision System?

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 Femoral Revision System?

The FDA product code for M-Vizion Femoral Revision System 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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