Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled 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 14, 2026, FDA's public records list Spineway with 7 510(k) clearances. The most recent is a 510(k) clearance dated Oct 10, 2023: VEOS Spinal Fixation 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 10, 2023 | VEOS Spinal Fixation SystemK231658 · NKB | 510(k) clearances |
| Sep 12, 2019 | mont blanc & mont blanc MIS Spinal SystemsK191726 · NKB | 510(k) clearances |
| Jan 12, 2017 | Ayers Rock Cervical interbody fusion systemK162694 · ODP | 510(k) clearances |
| Aug 4, 2016 | Mont Blanc and Mont Blanc MIS Spinal SystemsK161387 · NKB | 510(k) clearances |
| Dec 10, 2015 | Twin Peaks Lumbar Interbody Fusion SystemK152355 · MAX | 510(k) clearances |
| May 12, 2015 | Mont Blanc Spinal SystemK150185 · NKB | 510(k) clearances |
| May 7, 2015 | Blue Mountain Cervical Plate SystemK150036 · 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
