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FDA 510(k)

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer

K-Number: K161703 · 2016-11-04

ApplicantAap Implantate AG
Decision Date2016-11-04
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer is a medical device manufactured by Aap Implantate AG. It received FDA 510(k) clearance on 2016-11-04 under approval number K161703. 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 Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer?

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Aap Implantate AG. The 510(k) number is K161703.

When was LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer approved by the FDA?

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer received FDA 510(k) clearance on 2016-11-04, under approval number K161703.

What company makes LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer?

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer is manufactured by Aap Implantate AG.

What is the FDA product code for LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer?

The FDA product code for LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer is HRS.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07511478 Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle Fractures COMPLETED NCT06636136 Transtibial Osseointegration RECRUITING

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 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 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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