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FDA 510(k)

MPACT EXTENSION

K-Number: K122641 · 2012-09-28

ApplicantMedacta International
Decision Date2012-09-28
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MPACT EXTENSION is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2012-09-28 under 510(k) number K122641. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MPACT EXTENSION?

MPACT EXTENSION is a medical device that received FDA 510(k) clearance on 2012-09-28. The listed applicant is Medacta International. The 510(k) number is K122641.

When did MPACT EXTENSION receive FDA 510(k) clearance?

MPACT EXTENSION received FDA 510(k) clearance on 2012-09-28, under 510(k) number K122641.

Who is the listed applicant for MPACT EXTENSION?

The FDA 510(k) record lists Medacta International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MPACT EXTENSION?

The FDA product code for MPACT EXTENSION is LZO.

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Related Devices (Code: LZO)

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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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