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FDA 510(k)

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5

K-Number: K161696 · 2016-11-23

ApplicantAap Implantate AG
Decision Date2016-11-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is a medical device manufactured by Aap Implantate AG. It received FDA 510(k) clearance on 2016-11-23 under approval number K161696. 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 aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5?

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is a medical device that received FDA 510(k) clearance on 2016-11-23. It is manufactured by Aap Implantate AG. The 510(k) number is K161696.

When was aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 approved by the FDA?

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 received FDA 510(k) clearance on 2016-11-23, under approval number K161696.

What company makes aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5?

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is manufactured by Aap Implantate AG.

What is the FDA product code for aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5?

The FDA product code for aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is HRS.

Related Clinical Trials

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Other Devices by Aap 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 2.7/3.5 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 K211582LOQTEQ Proximal Humerus Plate 3.5 System

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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 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 K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.

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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