Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list SpineCraft with 18 510(k) clearances. The most recent is a 510(k) clearance dated Apr 16, 2026: ORIO-3D Cage 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.
| Apr 16, 2026 | ORIO-3D Cage SystemK253260 · ODP | 510(k) clearances |
| Mar 4, 2026 | ANTERIS Thoracolumbar Plate SystemK260015 · KWQ | 510(k) clearances |
| Jul 20, 2023 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemK223301 · OLO | 510(k) clearances |
| Dec 22, 2022 | ASTRA Spine SystemK223273 · NKB | 510(k) clearances |
| Sep 30, 2021 | ORIO-Ti Intervertebral Body Fusion Cage SystemK211935 · ODP | 510(k) clearances |
| Jun 3, 2021 | ASTRA Spine SystemK211323 · NKB | 510(k) clearances |
| Jul 6, 2018 | ASTRA-OCT Spine SystemK181350 · NKG | 510(k) clearances |
| May 22, 2015 | APEX-DL Spine SystemK143683 · NKB | 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
