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FDA 510(k)

Mecta-C Stand Alone

K-Number: K192906 · 2020-03-04

ApplicantMedacta International S.A.
Decision Date2020-03-04
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mecta-C Stand Alone 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 2020-03-04 under 510(k) number K192906. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mecta-C Stand Alone?

Mecta-C Stand Alone is a medical device that received FDA 510(k) clearance on 2020-03-04. The listed applicant is Medacta International S.A.. The 510(k) number is K192906.

When did Mecta-C Stand Alone receive FDA 510(k) clearance?

Mecta-C Stand Alone received FDA 510(k) clearance on 2020-03-04, under 510(k) number K192906.

Who is the listed applicant for Mecta-C Stand Alone?

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 Mecta-C Stand Alone?

The FDA product code for Mecta-C Stand Alone is OVE.

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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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