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 15, 2026, FDA's public records list Genesys Spine with 31 510(k) clearances. The most recent is a 510(k) clearance dated Oct 22, 2025: SIros-X 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.
| Oct 22, 2025 | SIros-X SystemK252322 · OUR | 510(k) clearances |
| Feb 7, 2025 | Genesys Spine AIS-C II Cervical Interbody Fusion SystemK242483 · OVE | 510(k) clearances |
| Mar 29, 2024 | Genesys Spine Sacroiliac Joint Fusion System with NavigationK233595 · OLO | 510(k) clearances |
| Dec 13, 2023 | Genesys Spine 3DP AIS-C II Cervical Interbody SystemK233594 · OVE | 510(k) clearances |
| Mar 9, 2022 | Genesys Spine 3DP Lumbar Interbody SystemK220096 · MAX | 510(k) clearances |
| Jan 8, 2020 | Genesys Spine 3DP Cervical Interbody SystemK191489 · OVE | 510(k) clearances |
| Dec 12, 2019 | Genesys Spine 3DP Lumbar Interbody SystemK182987 · MAX | 510(k) clearances |
| Oct 24, 2019 | Genesys Spine Binary® Lumbar Plate SystemK192678 · KWQ | 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
