CoreLink LLC
FDA Regulatory Profile
CoreLink LLC appears in FDA public data with 1 recall, 35 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0954-2023, Class II) was initiated on October 20, 2022. Its most recent 510(k) clearance was granted on December 8, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 35
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0954-2023 | Class II | CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208 | October 20, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate Syst | December 8, 2023 |
| K231494 | CoreLink Robotic Navigation Instruments | October 27, 2023 |
| K232116 | CoreLink Navigation Instruments | August 16, 2023 |
| K230329 | F3D Interbody System | June 6, 2023 |
| K230880 | CoreLink Navigation Instruments | May 2, 2023 |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | March 21, 2023 |
| K221776 | NextGen Pedicle Screw System | August 9, 2022 |
| K220973 | CoreLink Navigation Instruments | June 1, 2022 |
| K211417 | F3D-C2 Cervical Stand-Alone System | February 4, 2022 |
| K214059 | CoreLink Navigation Instruments | January 19, 2022 |
| K212825 | CoreLink Navigation Instruments | October 13, 2021 |
| K210539 | CoreLink Midline Fixation System | April 15, 2021 |
| K202637 | F3D Corpectomy System | December 23, 2020 |
| K200087 | F3D Cervical Stand-Alone Interbody Fusion System | June 15, 2020 |
| K200863 | Tiger® Occipital-Cervical-Thoracic Spinal Fixation System | April 28, 2020 |
| K182731 | Corelink Navigation Instruments | December 13, 2019 |
| K190016 | Lateral Plate System | June 12, 2019 |
| K183239 | CoreLink F3D Lateral System | December 19, 2018 |
| K180814 | CoreLink® M3 Stand-Alone Anterior Lumbar System | August 10, 2018 |
| K180556 | Corelink Foundation 3D Anterior Lumbar System | July 27, 2018 |