Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled 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 CG Bio with 6 510(k) clearances. The most recent is a 510(k) clearance dated Jun 23, 2026: CURASYS 2 (EMDN0003).
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.
| Jun 23, 2026 | CURASYS 2 (EMDN0003)K253199 · OMP | 510(k) clearances |
| Apr 9, 2026 | EASYMADE-TIK252251 · GXN | 510(k) clearances |
| May 8, 2025 | COLONNADE Posterior Screw Fixation SystemK250582 · NKB | 510(k) clearances |
| May 25, 2023 | Advanced LumFix Spinal Fixation SystemK222229 · NKB | 510(k) clearances |
| Oct 4, 2016 | LumFix Spinal Fixation SytemK160731 · MNI | 510(k) clearances |
| Nov 13, 2013 | KULAVACK122490 · OMP | 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
