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FDA 510(k)

MECTA-C

K-Number: K112862 · 2011-12-19

ApplicantMedacta International
Decision Date2011-12-19
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MECTA-C is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2011-12-19 under 510(k) number K112862. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECTA-C?

MECTA-C is a medical device that received FDA 510(k) clearance on 2011-12-19. The listed applicant is Medacta International. The 510(k) number is K112862.

When did MECTA-C receive FDA 510(k) clearance?

MECTA-C received FDA 510(k) clearance on 2011-12-19, under 510(k) number K112862.

Who is the listed applicant for MECTA-C?

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 MECTA-C?

The FDA product code for MECTA-C is ODP.

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Related Devices (Code: ODP)

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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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