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 Aegis Spine with 6 510(k) clearances. The most recent is a 510(k) clearance dated Jan 20, 2023: ZESPIN SI Joint 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.
| Jan 20, 2023 | ZESPIN SI Joint Fusion SystemK223521 · OUR | 510(k) clearances |
| Jan 11, 2023 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemK223719 · KWQ | 510(k) clearances |
| Nov 3, 2022 | ABTross ALIF Expandable Cage SystemK221719 · MAX | 510(k) clearances |
| Jun 30, 2022 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate SystemK221050 · OUR | 510(k) clearances |
| Feb 16, 2021 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate SystemK210035 · OUR | 510(k) clearances |
| Jan 29, 2021 | XYPAN Expandable Lumbar Cage SystemK203531 · MAX | 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
