Spinal Elements, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Spinal Elements, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Ventana® P/T Lumbar Interbody System, Ventana™ A Anterior Lumbar Interbody System, Luna® Ti Interbody Fusion System
49
Total
49
Cleared
0
Denied
Spinal Elements, Inc. has 49 FDA 510(k) cleared orthopedic devices. Based in Carlsbad, US.
Latest FDA clearance: May 2026. Active since 2007.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Spinal Elements, Inc.
49 devices
Cleared
May 15, 2026
Ventana® P/T Lumbar Interbody System
Orthopedic
87d
Cleared
Feb 25, 2026
Ventana™ A Anterior Lumbar Interbody System
Orthopedic
100d
Cleared
Feb 04, 2026
Luna® Ti Interbody Fusion System
Orthopedic
327d
Cleared
May 21, 2025
The Karma® Fixation System
Orthopedic
268d
Cleared
Feb 21, 2025
Primus Spinal Fixation System
Orthopedic
63d
Cleared
Aug 02, 2023
Sapphire X3 Anterior Cervical Plate System
Orthopedic
62d
Cleared
Jun 30, 2023
Ventana™ L Spinal System
Orthopedic
60d
Cleared
May 19, 2023
Ventana™ C Spinal System
Orthopedic
241d
Cleared
Dec 01, 2022
Mercury® II Spinal System
Orthopedic
104d
Cleared
Jun 30, 2021
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus...
Orthopedic
174d
Cleared
Mar 26, 2021
Lucent 3D Spinal System
Orthopedic
142d
Cleared
Dec 22, 2020
Lucent XP, Lucent XP Curved
Orthopedic
131d
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