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FDA 510(k)

LOQTEQ® VA Proximal Humerus Plate 3.5

K-Number: K254253 · 2026-03-24

ApplicantAap Implantate AG
Decision Date2026-03-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOQTEQ® VA Proximal Humerus Plate 3.5 is a medical device manufactured by Aap Implantate AG. It received FDA 510(k) clearance on 2026-03-24 under approval number K254253. 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 LOQTEQ® VA Proximal Humerus Plate 3.5?

LOQTEQ® VA Proximal Humerus Plate 3.5 is a medical device that received FDA 510(k) clearance on 2026-03-24. It is manufactured by Aap Implantate AG. The 510(k) number is K254253.

When was LOQTEQ® VA Proximal Humerus Plate 3.5 approved by the FDA?

LOQTEQ® VA Proximal Humerus Plate 3.5 received FDA 510(k) clearance on 2026-03-24, under approval number K254253.

What company makes LOQTEQ® VA Proximal Humerus Plate 3.5?

LOQTEQ® VA Proximal Humerus Plate 3.5 is manufactured by Aap Implantate AG.

What is the FDA product code for LOQTEQ® VA Proximal Humerus Plate 3.5?

The FDA product code for LOQTEQ® VA Proximal Humerus Plate 3.5 is HRS.

Related Clinical Trials

NCT01866501 Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site COMPLETED NCT01866514 Proximal Humerus Site for Anesthesia COMPLETED

Other Devices by Aap Implantate AG

K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 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 2.7/3.5 K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer K153034aap LOQTEQ VA Radius Set 2.5 K182818LOQTEQ VA Calcaneus Plate 3.5 K182785LOQTEQ VA Foot Plates 2.5

View all 11 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.

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