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FDA 510(k)

APTUS Clavicle System 2.8

K-Number: K260761 · 2026-06-05

ApplicantMedartis AG
Decision Date2026-06-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS Clavicle System 2.8 is the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K260761. 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 Clavicle System 2.8?

APTUS Clavicle System 2.8 is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Medartis AG. The 510(k) number is K260761.

When did APTUS Clavicle System 2.8 receive FDA 510(k) clearance?

APTUS Clavicle System 2.8 received FDA 510(k) clearance on 2026-06-05, under 510(k) number K260761.

Who is the listed applicant for APTUS Clavicle System 2.8?

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 Clavicle System 2.8?

The FDA product code for APTUS Clavicle System 2.8 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.

K260934TITAN Nail; APTUS K-Wire SystemK253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonK240613APTUS Elbow Dorsal Olecranon PlatesK232105APTUS Foot System 2.8-3.5K234062APTUS Hand Scaphoid Plates

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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.

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 KGK261351SALGINA 2.5mm Distal Radius SystemBonebridge AGK260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (LI.T.S. GmbHK261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC

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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