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FDA 510(k)

MectaLock Extension

K-Number: K203493 · 2021-02-22

Decision Date2021-02-22
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaLock Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-02-22 under approval number K203493. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MectaLock Extension?

MectaLock Extension is a medical device that received FDA 510(k) clearance on 2021-02-22. It is manufactured by Medacta International S.A.. The 510(k) number is K203493.

When was MectaLock Extension approved by the FDA?

MectaLock Extension received FDA 510(k) clearance on 2021-02-22, under approval number K203493.

What company makes MectaLock Extension?

MectaLock Extension is manufactured by Medacta International S.A..

What is the FDA product code for MectaLock Extension?

The FDA product code for MectaLock Extension is MAI.

Other Devices by Medacta International S.A.

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Related Devices (Code: MAI)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.