Spinal Elements

Timeline

1. May 15, 2026 FDA FDA 510(k) clearance: Ventana® P/T Lumbar Interbody System — K260506, May 15, 2026. Applicant at approval: Spinal Elements, Inc. source ↗
2. Feb 25, 2026 FDA FDA 510(k) clearance: Ventana™ A Anterior Lumbar Interbody System — K253559, Feb 25, 2026. Applicant at approval: Spinal Elements, Inc. source ↗
3. Feb 4, 2026 FDA FDA 510(k) clearance: Luna® Ti Interbody Fusion System — K250773, Feb 4, 2026. Applicant at approval: Spinal Elements, Inc. source ↗
4. May 21, 2025 FDA FDA 510(k) clearance: The Karma® Fixation System — K242527, May 21, 2025. Applicant at approval: Spinal Elements, Inc. source ↗
5. Feb 21, 2025 FDA FDA 510(k) clearance: Primus Spinal Fixation System — K243916, Feb 21, 2025. Applicant at approval: Spinal Elements, Inc. source ↗

FDA records (last 2 years)

• May 15, 2026 FDA 510(k) clearance: Ventana® P/T Lumbar Interbody System — K260506, May 15, 2026. Applicant at approval: Spinal Elements, Inc. source ↗
• Feb 25, 2026 FDA 510(k) clearance: Ventana™ A Anterior Lumbar Interbody System — K253559, Feb 25, 2026. Applicant at approval: Spinal Elements, Inc. source ↗
• Feb 4, 2026 FDA 510(k) clearance: Luna® Ti Interbody Fusion System — K250773, Feb 4, 2026. Applicant at approval: Spinal Elements, Inc. source ↗
• May 21, 2025 FDA 510(k) clearance: The Karma® Fixation System — K242527, May 21, 2025. Applicant at approval: Spinal Elements, Inc. source ↗
• Feb 21, 2025 FDA 510(k) clearance: Primus Spinal Fixation System — K243916, Feb 21, 2025. Applicant at approval: Spinal Elements, Inc. source ↗