Spinal Elements
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 4 spellings of its name, each linked to the record.
- 510(k) clearances: 50
- Device recalls: 24
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| May 15, 2026 | Ventana® P/T Lumbar Interbody SystemK260506 · MAX | 510(k) clearances |
| Feb 25, 2026 | Ventana™ A Anterior Lumbar Interbody SystemK253559 · OVD | 510(k) clearances |
| Feb 4, 2026 | Luna® Ti Interbody Fusion SystemK250773 · MAX | 510(k) clearances |
| May 21, 2025 | The Karma® Fixation SystemK242527 · MRW | 510(k) clearances |
| Feb 21, 2025 | Primus Spinal Fixation SystemK243916 · NKB | 510(k) clearances |
| Mar 27, 2024 | Lucent® XPK234150 · MAX | 510(k) clearances |
| Aug 2, 2023 | Sapphire X3 Anterior Cervical Plate SystemK231593 · KWQ | 510(k) clearances |
| Jun 30, 2023 | Ventana™ L Spinal SystemK231252 · MAX | 510(k) clearances |
| Apr 16, 2018 | AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody DeviceClass II · Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 | Device recalls |
Names and Identifiers
- Appears as
- Website
- spinalelements.com
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