Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 15, 2026, FDA's public records list Spineology with 53 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Dec 15, 2025: OptiMesh Multiplanar Expandable Interbody Fusion 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.
| Dec 15, 2025 | OptiMesh Multiplanar Expandable Interbody Fusion SystemK251302 · OQB | 510(k) clearances |
| Dec 4, 2025 | Spineology Navigation InstrumentsK251943 · OLO | 510(k) clearances |
| Sep 16, 2024 | The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access PoClass II · Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our sur | Device recalls |
| Nov 1, 2023 | OptiMesh Multiplanar Expandable Interbody Fusion SystemK230927 · OQB | 510(k) clearances |
| Oct 18, 2023 | OptiMesh Multiplanar Expandable Interbody Fusion SystemK231781 · OQB | 510(k) clearances |
| Aug 5, 2022 | Spineology Navigation InstrumentsK213876 · OLO | 510(k) clearances |
| Feb 19, 2021 | Duo Expandable Interbody Fusion SystemK210155 · MAX | 510(k) clearances |
| Sep 18, 2020 | Spineology Interbody Fusion SystemDEN200010 · OQB | 510(k) clearances |
| Aug 23, 2019 | Rampart™ One Lumbar Interbody Fusion SystemK192047 · OVD | 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
