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FDA 510(k)

APTUS® Ankle Trauma System 2.8/3.5

K-Number: K193633 · 2020-03-26

ApplicantMedartis AG
Decision Date2020-03-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS® Ankle Trauma System 2.8/3.5 is the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K193633. 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® Ankle Trauma System 2.8/3.5?

APTUS® Ankle Trauma System 2.8/3.5 is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Medartis AG. The 510(k) number is K193633.

When did APTUS® Ankle Trauma System 2.8/3.5 receive FDA 510(k) clearance?

APTUS® Ankle Trauma System 2.8/3.5 received FDA 510(k) clearance on 2020-03-26, under 510(k) number K193633.

Who is the listed applicant for APTUS® Ankle Trauma System 2.8/3.5?

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® Ankle Trauma System 2.8/3.5?

The FDA product code for APTUS® Ankle Trauma System 2.8/3.5 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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