Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

48 results for "Spinal Elements, Inc."
1–24 of 48
Cleared Feb 25, 2026
Ventana™ A Anterior Lumbar Interbody System
K253559 · OVD
Spinal Elements, Inc.
Orthopedic · 100d
Cleared Feb 04, 2026
Luna® Ti Interbody Fusion System
K250773 · MAX
Spinal Elements, Inc.
Orthopedic · 327d
Cleared May 21, 2025
The Karma® Fixation System
K242527 · MRW
Spinal Elements, Inc.
Orthopedic · 268d
Cleared Feb 21, 2025
Primus Spinal Fixation System
K243916 · NKB
Spinal Elements, Inc.
Orthopedic · 63d
Cleared Aug 02, 2023
Sapphire X3 Anterior Cervical Plate System
K231593 · KWQ
Spinal Elements, Inc.
Orthopedic · 62d
Cleared Jun 30, 2023
Ventana™ L Spinal System
K231252 · MAX
Spinal Elements, Inc.
Orthopedic · 60d
Cleared May 19, 2023
Ventana™ C Spinal System
K222833 · ODP
Spinal Elements, Inc.
Orthopedic · 241d
Cleared Dec 01, 2022
Mercury® II Spinal System
K222516 · NKB
Spinal Elements, Inc.
Orthopedic · 104d
Cleared Jun 30, 2021
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus...
K210044 · MAX
Spinal Elements, Inc.
Orthopedic · 174d
Cleared Mar 26, 2021
Lucent 3D Spinal System
K203254 · MAX
Spinal Elements, Inc.
Orthopedic · 142d
Cleared Dec 22, 2020
Lucent XP, Lucent XP Curved
K202298 · MAX
Spinal Elements, Inc.
Orthopedic · 131d
Cleared Jun 17, 2020
Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
K201029 · KWQ
Spinal Elements, Inc.
Orthopedic · 58d
Cleared Dec 19, 2019
Spinal Elements Navigated Instruments
K190881 · OLO
Spinal Elements, Inc.
Orthopedic · 259d
Cleared Sep 16, 2019
Mercury® Spinal System, Overwatch® Spinal System
K191576 · NKB
Spinal Elements, Inc.
Orthopedic · 94d
Cleared Apr 03, 2019
Karma® Fixation System
K190289 · OWI
Spinal Elements, Inc.
Orthopedic · 51d
Cleared Dec 10, 2018
Lucent® XP
K182584 · MAX
Spinal Elements, Inc.
Orthopedic · 81d
Cleared Nov 02, 2018
Spinal Elements Ti-Bond coated devices
K181837 · MAX
Spinal Elements, Inc.
Orthopedic · 115d
Cleared Sep 06, 2018
Spinal Elements Cerclage System
K180728 · OWI
Spinal Elements, Inc.
Orthopedic · 170d
Cleared Apr 10, 2018
Mercury® Spinal System
K172967 · NKB
Spinal Elements, Inc.
Orthopedic · 196d
Cleared Nov 29, 2017
Lucent®
K170235 · MAX
Spinal Elements, Inc.
Orthopedic · 308d
Cleared Aug 01, 2016
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody...
K153352 · OVE
Spinal Elements, Inc.
Orthopedic · 255d
Cleared Jul 28, 2016
Spinal Elements' Spinous Process Plate System
K160465 · PEK
Spinal Elements, Inc.
Orthopedic · 160d
Cleared Jun 09, 2016
Lucent Intervertebral Body Fusion Device
K152011 · MAX
Spinal Elements, Inc.
Orthopedic · 324d
Cleared Sep 03, 2015
Lotus Posterior Cervical/Thoracic Spinal System
K151705 · NKG
Spinal Elements, Inc.
Orthopedic · 71d