Medical Device Manufacturer · US , Carlsbad , CA

Spinal Elements, Inc.

48 submissions · 48 cleared · Since 2007
48
Total
48
Cleared
0
Denied

Spinal Elements, Inc. — FDA 510(k) Submissions

Spinal Elements, Inc. has submitted 48 FDA 510(k) premarket notifications since 2007, of which 48 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Thoracolumbosacral Pedicle Screw System, Appliance, Fixation, Spinal Intervertebral Body, Intervertebral Fusion Device With Integrated Fixation, Cervical, Intervertebral Fusion Device With Integrated Fixation, Lumbar . Use the specialty filter in the sidebar to narrow results.

48 devices
1–25 of 48
Ventana? A Anterior Lumbar Interbody System
K253559 · OVD Intervertebral Fusion... · Orthopedic
Feb 2026 100d
Luna? Ti Interbody Fusion System
K250773 · MAX Intervertebral Fusion... · Orthopedic
Feb 2026 327d
The Karma? Fixation System
K242527 · MRW System, Facet Screw... · Orthopedic
May 2025 268d
Primus Spinal Fixation System
K243916 · NKB Thoracolumbosacral... · Orthopedic
Feb 2025 63d
Sapphire X3 Anterior Cervical Plate System
K231593 · KWQ Appliance, Fixation,... · Orthopedic
Aug 2023 62d
Ventana? L Spinal System
K231252 · MAX Intervertebral Fusion... · Orthopedic
Jun 2023 60d
Ventana? C Spinal System
K222833 · ODP Intervertebral Fusion... · Orthopedic
May 2023 241d
Mercury? II Spinal System
K222516 · NKB Thoracolumbosacral... · Orthopedic
Dec 2022 104d
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
K210044 · MAX Intervertebral Fusion... · Orthopedic
Jun 2021 174d
Lucent 3D Spinal System
K203254 · MAX Intervertebral Fusion... · Orthopedic
Mar 2021 142d
Lucent XP, Lucent XP Curved
K202298 · MAX Intervertebral Fusion... · Orthopedic
Dec 2020 131d
Sapphire? Spinal System, Sapphire X Anterior Cervical Plate Spinal System
K201029 · KWQ Appliance, Fixation,... · Orthopedic
Jun 2020 58d
Spinal Elements Navigated Instruments
K190881 · OLO Orthopedic Stereotaxic... · Orthopedic
Dec 2019 259d
Mercury? Spinal System, Overwatch? Spinal System
K191576 · NKB Thoracolumbosacral... · Orthopedic
Sep 2019 94d
Karma? Fixation System
K190289 · OWI Bone Fixation Cerclage,... · Orthopedic
Apr 2019 51d
Lucent? XP
K182584 · MAX Intervertebral Fusion... · Orthopedic
Dec 2018 81d
Spinal Elements Ti-Bond coated devices
K181837 · MAX Intervertebral Fusion... · Orthopedic
Nov 2018 115d
Spinal Elements Cerclage System
K180728 · OWI Bone Fixation Cerclage,... · Orthopedic
Sep 2018 170d
Mercury? Spinal System
K172967 · NKB Thoracolumbosacral... · Orthopedic
Apr 2018 196d
Lucent?
K170235 · MAX Intervertebral Fusion... · Orthopedic
Nov 2017 308d
Vertu? & Vertu? Ti-Bond and Crystal? & Crystal? Ti-Bond Cervical Interbody System
K153352 · OVE Intervertebral Fusion... · Orthopedic
Aug 2016 255d
Spinal Elements' Spinous Process Plate System
K160465 · PEK Spinous Process Plate · Orthopedic
Jul 2016 160d
Lucent Intervertebral Body Fusion Device
K152011 · MAX Intervertebral Fusion... · Orthopedic
Jun 2016 324d
Lotus Posterior Cervical/Thoracic Spinal System
K151705 · NKG Posterior Cervical Screw... · Orthopedic
Sep 2015 71d
Mercury Spinal System
K151215 · NKB Thoracolumbosacral... · Orthopedic
Jun 2015 28d
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