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FDA 510(k)

MectaFix CL Fixation Button with Continuous Loop

K-Number: K193165 · 2020-02-10

ApplicantMedacta International S.A.
Decision Date2020-02-10
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaFix CL Fixation Button with Continuous Loop 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 2020-02-10 under 510(k) number K193165. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MectaFix CL Fixation Button with Continuous Loop?

MectaFix CL Fixation Button with Continuous Loop is a medical device that received FDA 510(k) clearance on 2020-02-10. The listed applicant is Medacta International S.A.. The 510(k) number is K193165.

When did MectaFix CL Fixation Button with Continuous Loop receive FDA 510(k) clearance?

MectaFix CL Fixation Button with Continuous Loop received FDA 510(k) clearance on 2020-02-10, under 510(k) number K193165.

Who is the listed applicant for MectaFix CL Fixation Button with Continuous Loop?

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 MectaFix CL Fixation Button with Continuous Loop?

The FDA product code for MectaFix CL Fixation Button with Continuous Loop is MBI.

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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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