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FDA 510(k)

LOQTEQ Proximal Humerus Plate 3.5 System

K-Number: K211582 · 2021-10-18

ApplicantAap Implantate AG
Decision Date2021-10-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOQTEQ Proximal Humerus Plate 3.5 System is a medical device manufactured by Aap Implantate AG. It received FDA 510(k) clearance on 2021-10-18 under approval number K211582. 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 Proximal Humerus Plate 3.5 System?

LOQTEQ Proximal Humerus Plate 3.5 System is a medical device that received FDA 510(k) clearance on 2021-10-18. It is manufactured by Aap Implantate AG. The 510(k) number is K211582.

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

LOQTEQ Proximal Humerus Plate 3.5 System received FDA 510(k) clearance on 2021-10-18, under approval number K211582.

What company makes LOQTEQ Proximal Humerus Plate 3.5 System?

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

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

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

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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

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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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