Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list CoreLink with 35 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Dec 8, 2023: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Latera….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Dec 8, 2023 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemK231743 · MAX | 510(k) clearances |
| Oct 27, 2023 | CoreLink Robotic Navigation InstrumentsK231494 · OLO | 510(k) clearances |
| Aug 16, 2023 | CoreLink Navigation InstrumentsK232116 · OLO | 510(k) clearances |
| Jun 6, 2023 | F3D Interbody SystemK230329 · ODP | 510(k) clearances |
| May 2, 2023 | CoreLink Navigation InstrumentsK230880 · OLO | 510(k) clearances |
| Mar 21, 2023 | Entasis 3D Dual-Lead Sacroiliac Implant SystemK223708 · OUR | 510(k) clearances |
| Oct 20, 2022 | CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208Class II · Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather t | Device recalls |
| Aug 9, 2022 | NextGen Pedicle Screw SystemK221776 · NKB | 510(k) clearances |
| Jun 1, 2022 | CoreLink Navigation InstrumentsK220973 · OLO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
