Medical device makerLabelled 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 Aurora Spine with 10 510(k) clearances. The most recent is a 510(k) clearance dated Mar 24, 2025: AERO MIS Facet 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.
| Mar 24, 2025 | AERO MIS Facet Fusion SystemK243865 · MRW | 510(k) clearances |
| Oct 3, 2022 | SILO TFX MIS Sacroiliac Joint Fixation SystemK221047 · OUR | 510(k) clearances |
| Jul 8, 2022 | ZIP™ MIS Interspinous Fusion SystemK221399 · PEK | 510(k) clearances |
| May 27, 2022 | SOLO-LK220610 · OVD | 510(k) clearances |
| Aug 2, 2021 | DEXA-C Cervical Interbody SystemK210521 · ODP | 510(k) clearances |
| Mar 23, 2021 | APOLLO Anterior Cervical Plate (ACP) SystemK210325 · KWQ | 510(k) clearances |
| Nov 17, 2014 | ZIP MIS INTERSPINOUS FUSION SYSTEMK141317 · PEK | 510(k) clearances |
| Apr 17, 2014 | ZIP MIS INTERSPINOUS FUSION SYSTEMK140715 · PEK | 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
