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FDA 510(k)

APTUS CMC-I Fusion Plate System

K-Number: K181009 · 2018-08-24

ApplicantMedartis AG
Decision Date2018-08-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS CMC-I Fusion Plate System is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2018-08-24 under approval number K181009. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTUS CMC-I Fusion Plate System?

APTUS CMC-I Fusion Plate System is a medical device that received FDA 510(k) clearance on 2018-08-24. It is manufactured by Medartis AG. The 510(k) number is K181009.

When was APTUS CMC-I Fusion Plate System approved by the FDA?

APTUS CMC-I Fusion Plate System received FDA 510(k) clearance on 2018-08-24, under approval number K181009.

What company makes APTUS CMC-I Fusion Plate System?

APTUS CMC-I Fusion Plate System is manufactured by Medartis AG.

What is the FDA product code for APTUS CMC-I Fusion Plate System?

The FDA product code for APTUS CMC-I Fusion Plate System is HRS.

Related Clinical Trials

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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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