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FDA 510(k)

MectaLIF Anterior Simple

K-Number: K200048 · 2020-03-09

ApplicantMedacta International S.A.
Decision Date2020-03-09
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaLIF Anterior Simple 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 2020-03-09 under 510(k) number K200048. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MectaLIF Anterior Simple?

MectaLIF Anterior Simple is a medical device that received FDA 510(k) clearance on 2020-03-09. The listed applicant is Medacta International S.A.. The 510(k) number is K200048.

When did MectaLIF Anterior Simple receive FDA 510(k) clearance?

MectaLIF Anterior Simple received FDA 510(k) clearance on 2020-03-09, under 510(k) number K200048.

Who is the listed applicant for MectaLIF Anterior Simple?

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 MectaLIF Anterior Simple?

The FDA product code for MectaLIF Anterior Simple is MAX.

Other records listing Medacta International S.A. as applicant

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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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