Company · US
Spinal Elements, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2026. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (3 in 12 months)
24recalls (0 in 12 months)
24recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 33 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 19 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| OWI | Bone Fixation Cerclage, Sublaminar | 2 |
| FST | Light, Surgical, Fiberoptic | 1 |
| JDQ | Cerclage, Fixation | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
| NKG | Posterior Cervical Screw System | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
| PEK | Spinous Process Plate | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2026 | K260506 | Ventana® P/T Lumbar Interbody System Spinal Elements, Inc. | MAX |
| Feb 25, 2026 | K253559 | Ventana A Anterior Lumbar Interbody System Spinal Elements, Inc. | OVD |
| Feb 4, 2026 | K250773 | Luna® Ti Interbody Fusion System Spinal Elements, Inc. | MAX |
| May 21, 2025 | K242527 | The Karma® Fixation System Spinal Elements, Inc. | MRW |
| Feb 21, 2025 | K243916 | Primus Spinal Fixation System Spinal Elements, Inc. | NKB |
| Mar 27, 2024 | K234150 | Lucent® XP Spinal Elements | MAX |
| Aug 2, 2023 | K231593 | Sapphire X3 Anterior Cervical Plate System Spinal Elements, Inc. | KWQ |
| Jun 30, 2023 | K231252 | Ventana L Spinal System Spinal Elements, Inc. | MAX |
| May 19, 2023 | K222833 | Ventana C Spinal System Spinal Elements, Inc. | ODP |
| Dec 1, 2022 | K222516 | Mercury® II Spinal System Spinal Elements, Inc. | NKB |
| Jun 30, 2021 | K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP S Spinal Elements, Inc. | MAX |
| Mar 26, 2021 | K203254 | Lucent 3D Spinal System Spinal Elements, Inc. | MAX |
| Dec 22, 2020 | K202298 | Lucent XP, Lucent XP Curved Spinal Elements, Inc. | MAX |
| Jun 17, 2020 | K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System Spinal Elements, Inc. | KWQ |
| Dec 19, 2019 | K190881 | Spinal Elements Navigated Instruments Spinal Elements, Inc. | OLO |
| Sep 16, 2019 | K191576 | Mercury® Spinal System, Overwatch® Spinal System Spinal Elements, Inc. | NKB |
| Apr 3, 2019 | K190289 | Karma® Fixation System Spinal Elements, Inc. | OWI |
| Dec 10, 2018 | K182584 | Lucent® XP Spinal Elements, Inc. | MAX |
| Nov 2, 2018 | K181837 | Spinal Elements Ti-Bond coated devices Spinal Elements, Inc. | MAX |
| Sep 6, 2018 | K180728 | Spinal Elements Cerclage System Spinal Elements, Inc. | OWI |
| Apr 10, 2018 | K172967 | Mercury® Spinal System Spinal Elements, Inc. | NKB |
| Nov 29, 2017 | K170235 | Lucent® Spinal Elements, Inc. | MAX |
| Aug 1, 2016 | K153352 | Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System Spinal Elements, Inc. | OVE |
| Jul 28, 2016 | K160465 | Spinal Elements' Spinous Process Plate System Spinal Elements, Inc. | PEK |
| Jun 9, 2016 | K152011 | Lucent Intervertebral Body Fusion Device Spinal Elements, Inc. | MAX |
| Sep 3, 2015 | K151705 | Lotus Posterior Cervical/Thoracic Spinal System Spinal Elements, Inc. | NKG |
| Jun 3, 2015 | K151215 | Mercury Spinal System Spinal Elements, Inc. | NKB |
| May 19, 2015 | K150061 | Lucent; Lucent Ti-Bond Systems Spinal Elements, Inc. | MAX |
| Dec 10, 2014 | K133218 | Crystal ®; Mosaic ®; Vertu ® Spinal Elements, Inc. | OVE |
| Aug 22, 2014 | K141372 | MERCURY SPINAL SYSTEM Spinal Elements, Inc. | NKB |
| Oct 24, 2013 | K131427 | LOTUS Spinal Elements, Inc. | KWP |
| Feb 21, 2013 | K122967 | LUCENT Spinal Elements, Inc. | MAX |
| Jan 10, 2013 | K122771 | SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM Spinal Elements, Inc. | OVE |
| Jul 30, 2012 | K120467 | SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM Spinal Elements, Inc. | NKB |
| Jul 3, 2012 | K120177 | SPINAL ELEMENTS CERCLAGE SYSTEM Spinal Elements, Inc. | JDQ |
| May 23, 2012 | K110632 | LUCENT OR LUCENT MAGNUM Spinal Elements, Inc. | MAX |
| Oct 14, 2010 | K101848 | SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM Spinal Elements, Inc. | KWQ |
| Jul 1, 2009 | K091587 | MERCURY SPINAL SYSTEM Spinal Elements, Inc. | NKB |
| Feb 18, 2009 | K082992 | AXXION LIGHT GUIDE Spinal Elements, Inc. | FST |
| Feb 13, 2009 | K083475 | LUCENT MAGNUM Spinal Elements, Inc. | OVD |
| Jan 22, 2009 | K082353 | MERCURY SPINAL SYSTEM Spinal Elements, Inc. | NKB |
| Dec 3, 2008 | K083230 | MERCURY SPINAL SYSTEM Spinal Elements, Inc. | NKB |
| Sep 11, 2008 | K081711 | LUCENT MAGNUM+ Spinal Elements, Inc. | OVD |
| Aug 5, 2008 | K081968 | MODIFICATION TO LUCENT Spinal Elements, Inc. | MAX |
| Jul 14, 2008 | K081418 | SPINAL ELEMENTS BUTTRESS PLATE SYSTEM Spinal Elements, Inc. | KWQ |
| Jan 24, 2008 | K073351 | CRYSTAL Spinal Elements, Inc. | ODP |
| Dec 26, 2007 | K073348 | LUCENT MAGNUM Spinal Elements, Inc. | MAX |
| Nov 9, 2007 | K071724 | LUCENT Spinal Elements, Inc. | MAX |
| Oct 23, 2007 | K071833 | MOSAIC DEVICES Spinal Elements, Inc. | OVE |
| Oct 12, 2007 | K071914 | MERCURY SPINAL SYSTEM Spinal Elements, Inc. | NKB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2018 | Spinal Elements AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11
The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion proc Open, Classified |
MAX | K150395 |
| May 11, 2015 | Spinal Elements, Inc Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the n Terminated |
NKB | K071914 |
| Jan 5, 2015 | Spinal Elements, Inc Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000
This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months no Terminated |
MAX | K110632 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 400mm Straight Rod,
Part Number: 60101-400.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 120mm Straight Rod,
Part Number: 60101-120.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 110mm Straight Rod,
Part Number: 60101-110.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 100mm Straight Rod,
Part Number: 60101-100.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 90mm Straight Rod,
Part Number: 60101-090.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 80mm Straight Rod,
Part Number: 60101-080.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 70mm Straight Rod,
Part Number: 60101-070.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 60mm Straight Rod,
Part Number: 60101-060.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 50mm Straight Rod,
Part Number: 60101-050.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 40mm Straight Rod,
Part Number: 60101-040.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 30mm Straight Rod,
Part Number: 60101-030.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod,
Part Number: 60100-120.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod,
Part Number: 60100-110.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod,
Part Number: 60100-100.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod,
Part Number: 60100-090.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod,
Part Number: 60100-080.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod,
Part Number: 60100-070.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod,
Part Number: 60100-060.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod,
Part Number: 60100-050.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod,
Part Number: 60100-040.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod,
Part Number: 60100-030.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |