FDA 510(k) Applications Submitted by CoreLink, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K152237 |
08/10/2015 |
The Entasis Dual-Lead Sacroiliac Implant |
CoreLink, LLC |
| K110321 |
02/03/2011 |
TIGER SPINE SYSTEM |
CORELINK, LLC |
| K162496 |
09/07/2016 |
Foundation 3D Interbody |
CoreLink, LLC |
| K163104 |
11/07/2016 |
TerraceÖ Anterior Cervical Plate System |
CoreLink, LLC |
| K180814 |
03/29/2018 |
CoreLink« M3Ö Stand-Alone Anterior Lumbar System |
CoreLink, LLC |
| K200863 |
04/01/2020 |
Tiger« Occipital-Cervical-Thoracic Spinal Fixation System |
CoreLink, LLC |
| K190016 |
01/03/2019 |
Lateral Plate System |
CoreLink, LLC |
| K200087 |
01/15/2020 |
F3D Cervical Stand-Alone Interbody Fusion System |
CoreLink, LLC |
| K230329 |
02/06/2023 |
F3D Interbody System |
Corelink, LLC |
| K210539 |
02/24/2021 |
CoreLink Midline Fixation System |
CoreLink, LLC |
| K230880 |
03/30/2023 |
CoreLink Navigation Instruments |
CoreLink, LLC |
| K220973 |
04/04/2022 |
CoreLink Navigation Instruments |
CoreLink, LLC |
| K211417 |
05/07/2021 |
F3D-C2 Cervical Stand-Alone System |
CoreLink, LLC |
| K231494 |
05/23/2023 |
CoreLink Robotic Navigation Instruments |
CoreLink, LLC |
| K231743 |
06/14/2023 |
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System |
CoreLink, LLC |
| K221776 |
06/21/2022 |
NextGen Pedicle Screw System |
CoreLink, LLC |
| K232116 |
07/17/2023 |
CoreLink Navigation Instruments |
CoreLink, LLC |
| K212825 |
09/03/2021 |
CoreLink Navigation Instruments |
CoreLink, LLC |
| K202637 |
09/11/2020 |
F3D Corpectomy System |
CoreLink, LLC |
| K183239 |
11/20/2018 |
CoreLink F3DÖ Lateral System |
Corelink, LLC |
| K223708 |
12/12/2022 |
Entasis 3D Dual-Lead Sacroiliac Implant System |
CoreLink, LLC |
| K214059 |
12/27/2021 |
CoreLink Navigation Instruments |
CoreLink, LLC |
| K180556 |
03/01/2018 |
Corelink Foundation 3D Anterior Lumbar System |
Corelink, LLC |
|
|
