Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Corelink, LLC — Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
226 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Inte | Corelink, LLC | 2023-12-08 | 177 | 0 |
| K231494 | CoreLink Robotic Navigation Instruments | Corelink, LLC | 2023-10-27 | 157 | 0 |
| K232116 | CoreLink Navigation Instruments | Corelink, LLC | 2023-08-16 | 30 | 0 |
| K230329 | F3D Interbody System | Corelink, LLC | 2023-06-06 | 120 | 0 |
| K230880 | CoreLink Navigation Instruments | Corelink, LLC | 2023-05-02 | 33 | 0 |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | 2023-03-21 | 99 | 0 |
| K221776 | NextGen Pedicle Screw System | Corelink, LLC | 2022-08-09 | 49 | 0 |
| K220973 | CoreLink Navigation Instruments | Corelink, LLC | 2022-06-01 | 58 | 0 |
| K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022-02-04 | 273 | 0 |
| K214059 | CoreLink Navigation Instruments | Corelink, LLC | 2022-01-19 | 23 | 0 |
| K212825 | CoreLink Navigation Instruments | Corelink, LLC | 2021-10-13 | 40 | 0 |
| K210539 | CoreLink Midline Fixation System | Corelink, LLC | 2021-04-15 | 50 | 0 |
| K202637 | F3D Corpectomy System | Corelink, LLC | 2020-12-23 | 103 | 0 |
| K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | 2020-06-15 | 152 | 0 |
| K200863 | Tiger® Occipital-Cervical-Thoracic Spinal Fixation System | Corelink, LLC | 2020-04-28 | 27 | 0 |
| K182731 | Corelink Navigation Instruments | Corelink, LLC | 2019-12-13 | 441 | 0 |
| K190016 | Lateral Plate System | Corelink, LLC | 2019-06-12 | 160 | 0 |
| K183239 | CoreLink F3D™ Lateral System | Corelink, LLC | 2018-12-19 | 29 | 0 |
| K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar System | Corelink, LLC | 2018-08-10 | 134 | 0 |
| K180556 | Corelink Foundation 3D Anterior Lumbar System | Corelink, LLC | 2018-07-27 | 148 | 0 |
| K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017-06-21 | 226 | 0 |
| K162496 | Foundation 3D Interbody | Corelink, LLC | 2017-05-04 | 239 | 0 |
| K152237 | The Entasis Dual-Lead Sacroiliac Implant | Corelink, LLC | 2016-02-04 | 178 | 0 |
| K150847 | Foundation Interbody Devices | Corelink, LLC | 2015-08-13 | 135 | 0 |
| K133369 | TIGER SPINE SYSTEM | Corelink, LLC | 2014-01-14 | 74 | 0 |
| K132994 | ANODYNE ANTERIOR CERVICAL PLATE SYSTEM | Corelink, LLC | 2013-12-05 | 72 | 0 |
| K132504 | TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM | Corelink, LLC | 2013-11-25 | 105 | 0 |
| K131250 | TIGER SPINE SYSTEM | Corelink, LLC | 2013-09-10 | 131 | 0 |
| K121514 | ANODYNE ANTERIOR CERVICAL PLATE SYSTEM | Corelink, LLC | 2012-12-14 | 206 | 0 |
| K121791 | ZOU ANTERIOR LUMBAR PLATE SYSTEM | Corelink, LLC | 2012-11-19 | 153 | 0 |
| K121728 | TIGER SPINE SYSTEM | Corelink, LLC | 2012-10-05 | 115 | 0 |
| K120696 | TIGER SPINE SYSTEM | Corelink, LLC | 2012-04-02 | 26 | 0 |
| K113058 | TIGER SPINE SYSTEM | Corelink, LLC | 2012-03-29 | 167 | 0 |
| K110321 | TIGER SPINE SYSTEM | Corelink, LLC | 2011-05-25 | 111 | 0 |
| K073440 | FOUNDATION CAGE | Corelink, LLC | 2008-04-24 | 139 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda