FDA 510(k)

APTUS® Proximal Humerus System

K-Number: K181425 · 2018-08-05

Decision Date2018-08-05

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

APTUS® Proximal Humerus System is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2018-08-05 under approval number K181425. 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® Proximal Humerus System?

APTUS® Proximal Humerus System is a medical device that received FDA 510(k) clearance on 2018-08-05. It is manufactured by Medartis AG. The 510(k) number is K181425.

When was APTUS® Proximal Humerus System approved by the FDA?

APTUS® Proximal Humerus System received FDA 510(k) clearance on 2018-08-05, under approval number K181425.

What company makes APTUS® Proximal Humerus System?

APTUS® Proximal Humerus System is manufactured by Medartis AG.

What is the FDA product code for APTUS® Proximal Humerus System?

The FDA product code for APTUS® Proximal Humerus System is HRS.

Related Clinical Trials

NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT05019664 Affixus Natural Nail System Humeral Nail PMCF ACTIVE_NOT_RECRUITING NCT01866501 Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site COMPLETED NCT07102160 Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking RECRUITING NCT07355270 A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOleRability, and Effectiveness for Proximal Intestinal Mucosal Ablation in Patients With Type 2 Diabetes Mellitus (RESTORE-1 Study) RECRUITING NCT01866514 Proximal Humerus Site for Anesthesia COMPLETED

Other Devices by Medartis AG

K172170APTUS(R) Wrist 2.5 System K161861APTUS® Coronoid 2.0 K181009APTUS CMC-I Fusion Plate System K192297APTUS Wrist Arthrodesis Plates K191848APTUS Wrist Spanning Plates 2.5 K191636APTUS Foot System

View all 22 devices →

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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.