Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Republic Spine with 7 510(k) clearances. The most recent is a 510(k) clearance dated May 26, 2023: Dark Star Deformity Pedicle Screw System.
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.
| May 26, 2023 | Dark Star Deformity Pedicle Screw SystemK223096 · NKB | 510(k) clearances |
| Sep 27, 2021 | Dark Star Navigation Instrument SystemK212028 · OLO | 510(k) clearances |
| Mar 5, 2021 | Republic Spine Dark Star Spinal SystemK201420 · NKB | 510(k) clearances |
| Sep 12, 2019 | Republic Spine Restore Intervertebral Body Fusion SystemK190398 · MAX | 510(k) clearances |
| Jun 19, 2019 | Republic Spine Restore Cervical Interbody Fusion SystemK190889 · ODP | 510(k) clearances |
| Jul 25, 2018 | Republic Spine Dark Star Spinal SystemK181495 · NKB | 510(k) clearances |
| Apr 29, 2015 | Republic Spine Dark Star Spinal SystemK150283 · MNH | 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
