Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

APTUS Wrist Arthrodesis Plates

K-Number: K192297 · 2019-11-08

ApplicantMedartis AG
Decision Date2019-11-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS Wrist Arthrodesis Plates is the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K192297. 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 Wrist Arthrodesis Plates?

APTUS Wrist Arthrodesis Plates is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Medartis AG. The 510(k) number is K192297.

When did APTUS Wrist Arthrodesis Plates receive FDA 510(k) clearance?

APTUS Wrist Arthrodesis Plates received FDA 510(k) clearance on 2019-11-08, under 510(k) number K192297.

Who is the listed applicant for APTUS Wrist Arthrodesis Plates?

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 Wrist Arthrodesis Plates?

The FDA product code for APTUS Wrist Arthrodesis Plates 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

View all 24 devices →

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.

↑