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Spinal Elements, Inc. FDA Approvals
0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Ventana® P/T Lumbar Interbody System510(k)May 15, 2026Orthopedic |
| Ventana A Anterior Lumbar Interbody System510(k)Feb 25, 2026Orthopedic |
| Luna® Ti Interbody Fusion System510(k)Feb 4, 2026Orthopedic |
| The Karma® Fixation System510(k)May 21, 2025 |
| Primus Spinal Fixation System510(k)Feb 21, 2025Orthopedic |
| Sapphire X3 Anterior Cervical Plate System510(k)Aug 2, 2023Orthopedic |
| Ventana L Spinal System510(k)Jun 30, 2023Orthopedic |
| Ventana C Spinal System510(k)May 19, 2023Orthopedic |
| Mercury® II Spinal System510(k)Dec 1, 2022Orthopedic |
| Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System510(k)Jun 30, 2021Orthopedic |
| Lucent 3D Spinal System510(k)Mar 26, 2021Orthopedic |