CoreLink LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
35
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0954-2023Class IICoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208October 20, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystDecember 8, 2023
K231494CoreLink Robotic Navigation InstrumentsOctober 27, 2023
K232116CoreLink Navigation InstrumentsAugust 16, 2023
K230329F3D Interbody SystemJune 6, 2023
K230880CoreLink Navigation InstrumentsMay 2, 2023
K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemMarch 21, 2023
K221776NextGen Pedicle Screw SystemAugust 9, 2022
K220973CoreLink Navigation InstrumentsJune 1, 2022
K211417F3D-C2 Cervical Stand-Alone SystemFebruary 4, 2022
K214059CoreLink Navigation InstrumentsJanuary 19, 2022
K212825CoreLink Navigation InstrumentsOctober 13, 2021
K210539CoreLink Midline Fixation SystemApril 15, 2021
K202637F3D Corpectomy SystemDecember 23, 2020
K200087F3D Cervical Stand-Alone Interbody Fusion SystemJune 15, 2020
K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemApril 28, 2020
K182731Corelink Navigation InstrumentsDecember 13, 2019
K190016Lateral Plate SystemJune 12, 2019
K183239CoreLink F3D™ Lateral SystemDecember 19, 2018
K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemAugust 10, 2018
K180556Corelink Foundation 3D Anterior Lumbar SystemJuly 27, 2018