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FDA 510(k)

Mecta-C Stand Alone Extension

K-Number: K203076 · 2020-11-06

ApplicantMedacta International S.A.
Decision Date2020-11-06
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mecta-C Stand Alone Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2020-11-06 under approval number K203076. 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 Extension?

Mecta-C Stand Alone Extension is a medical device that received FDA 510(k) clearance on 2020-11-06. It is manufactured by Medacta International S.A.. The 510(k) number is K203076.

When was Mecta-C Stand Alone Extension approved by the FDA?

Mecta-C Stand Alone Extension received FDA 510(k) clearance on 2020-11-06, under approval number K203076.

What company makes Mecta-C Stand Alone Extension?

Mecta-C Stand Alone Extension is manufactured by Medacta International S.A..

What is the FDA product code for Mecta-C Stand Alone Extension?

The FDA product code for Mecta-C Stand Alone Extension 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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