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FDA 510(k)

MectaLock Extension

K-Number: K203493 · 2021-02-22

ApplicantMedacta International S.A.
Decision Date2021-02-22
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaLock Extension 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 2021-02-22 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K203493.

When did MectaLock Extension receive FDA 510(k) clearance?

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

Who is the listed applicant for MectaLock Extension?

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 MectaLock Extension?

The FDA product code for MectaLock Extension is MAI.

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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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