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FDA 510(k)

MECTALIF TRANSFORAMINAL

K-Number: K120024 · 2012-02-28

ApplicantMedacta International S.A.
Decision Date2012-02-28
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MECTALIF TRANSFORAMINAL 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 2012-02-28 under 510(k) number K120024. 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 TRANSFORAMINAL?

MECTALIF TRANSFORAMINAL is a medical device that received FDA 510(k) clearance on 2012-02-28. The listed applicant is Medacta International S.A.. The 510(k) number is K120024.

When did MECTALIF TRANSFORAMINAL receive FDA 510(k) clearance?

MECTALIF TRANSFORAMINAL received FDA 510(k) clearance on 2012-02-28, under 510(k) number K120024.

Who is the listed applicant for MECTALIF TRANSFORAMINAL?

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 TRANSFORAMINAL?

The FDA product code for MECTALIF TRANSFORAMINAL is MAX.

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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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