Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

aap LOQTEQ VA Radius Set 2.5

K-Number: K153034 · 2016-01-21

ApplicantAap Implantate AG
Decision Date2016-01-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

aap LOQTEQ VA Radius Set 2.5 is a medical device manufactured by Aap Implantate AG. It received FDA 510(k) clearance on 2016-01-21 under approval number K153034. 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 VA Radius Set 2.5?

aap LOQTEQ VA Radius Set 2.5 is a medical device that received FDA 510(k) clearance on 2016-01-21. It is manufactured by Aap Implantate AG. The 510(k) number is K153034.

When was aap LOQTEQ VA Radius Set 2.5 approved by the FDA?

aap LOQTEQ VA Radius Set 2.5 received FDA 510(k) clearance on 2016-01-21, under approval number K153034.

What company makes aap LOQTEQ VA Radius Set 2.5?

aap LOQTEQ VA Radius Set 2.5 is manufactured by Aap Implantate AG.

What is the FDA product code for aap LOQTEQ VA Radius Set 2.5?

The FDA product code for aap LOQTEQ VA Radius Set 2.5 is HRS.

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 K182818LOQTEQ VA Calcaneus Plate 3.5 K182785LOQTEQ VA Foot Plates 2.5 K211582LOQTEQ Proximal Humerus Plate 3.5 System

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.

↑