AAP Implantate Ag

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
36
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1675-2020Class IIaap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00November 28, 2019
Z-0731-2020Class IIIINTEGRA, Drill CS 4.5, quick coupling single use, REF 430453January 25, 2019
Z-0732-2020Class IIIINTEGRA, Drill CS 4.0, quick coupling single use, REF 430425January 25, 2019
Z-1019-2019Class IIaap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are January 11, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K233008Cannulated Headless Bone ScrewsJune 5, 2024
K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemMarch 17, 2023
K211582LOQTEQ Proximal Humerus Plate 3.5 SystemOctober 18, 2021
K210043LOQTEQ Distal Lateral Femur Plate 4.5 SystemMarch 3, 2021
K182818LOQTEQ VA Calcaneus Plate 3.5August 1, 2019
K182785LOQTEQ VA Foot Plates 2.5June 19, 2019
K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5November 23, 2016
K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal AnNovember 22, 2016
K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherNovember 4, 2016
K153034aap LOQTEQ VA Radius Set 2.5January 21, 2016
K150974aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, TitaniumApril 29, 2015
K141949CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUMSeptember 12, 2014
K141823AAP LOQTEC CLAVICLE PLATES 2.7/3.5August 7, 2014
K140607AAP LOQTEC(R) OLECRANON PLATEMay 8, 2014
K133675AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5January 23, 2014
K132787LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATEDecember 24, 2013
K131782LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5November 18, 2013
K131459AAP K-WIRE, STEINMANN PIN, CERCLAGE WIREOctober 17, 2013
K132554AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5October 3, 2013
K130590AAP CANNULATED SCREW 2.0April 22, 2013