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FDA 510(k)

INTRAFIX(TM) Advance Tibial Fastener System

K-Number: K160804 · 2016-07-19

ApplicantMedos International SARL
Decision Date2016-07-19
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTRAFIX(TM) Advance Tibial Fastener System is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2016-07-19 under 510(k) number K160804. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAFIX(TM) Advance Tibial Fastener System?

INTRAFIX(TM) Advance Tibial Fastener System is a medical device that received FDA 510(k) clearance on 2016-07-19. The listed applicant is Medos International SARL. The 510(k) number is K160804.

When did INTRAFIX(TM) Advance Tibial Fastener System receive FDA 510(k) clearance?

INTRAFIX(TM) Advance Tibial Fastener System received FDA 510(k) clearance on 2016-07-19, under 510(k) number K160804.

Who is the listed applicant for INTRAFIX(TM) Advance Tibial Fastener System?

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

What is the FDA product code for INTRAFIX(TM) Advance Tibial Fastener System?

The FDA product code for INTRAFIX(TM) Advance Tibial Fastener System is MAI.

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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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