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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 the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 2018-08-24 under 510(k) 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. The listed applicant is Medartis AG. The 510(k) number is K181009.

When did APTUS CMC-I Fusion Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for APTUS CMC-I Fusion Plate System?

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

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.

Other records listing Medartis AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260761APTUS Clavicle System 2.8K260934TITAN Nail; APTUS K-Wire SystemK253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonK240613APTUS Elbow Dorsal Olecranon PlatesK232105APTUS Foot System 2.8-3.5

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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