Data / Medical devices / United States / Spinal Elements, Inc.
Spinal Elements, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 99 510(k) clearances
Spinal Elements, Inc. is registered with the FDA (registration 3004893332) in Carlsbad, CA, United States. It lists 29 device types. The FDA files 99 510(k) clearances under its listings, the newest dated May 15, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004893332
- Address
- 3115 Melrose Dr Suite 200, Carlsbad, CA, United States, 92010
- Owner or operator
- Spinal Elements (9048980)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 5, 2006
- Registered through
- 2026
- Brand names listed
- Access Portal, Adaptor, Awl, Box Chisel, Broach, Caliper, Cannula, Chisel and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2026 | K260506 | Ventana® P/T Lumbar Interbody System | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| February 25, 2026 | K253559 | Ventana A Anterior Lumbar Interbody System | OVD | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| February 4, 2026 | K250773 | Luna® Ti Interbody Fusion System | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| May 21, 2025 | K242527 | The Karma® Fixation System | MRW | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| February 21, 2025 | K243916 | Primus Spinal Fixation System | NKB | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| March 27, 2024 | K234150 | Lucent® XP | MAX | Substantially Equivalent | Spinal Elements | accessdata.fda.gov |
| August 2, 2023 | K231593 | Sapphire X3 Anterior Cervical Plate System | KWQ | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| June 30, 2023 | K231252 | Ventana L Spinal System | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| May 19, 2023 | K222833 | Ventana C Spinal System | ODP | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| December 1, 2022 | K222516 | Mercury® II Spinal System | NKB | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| June 30, 2021 | K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| March 26, 2021 | K203254 | Lucent 3D Spinal System | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| December 22, 2020 | K202298 | Lucent XP, Lucent XP Curved | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| July 2, 2020 | K193172 | Luna XD Ti Interbody Fusion System | MAX | Substantially Equivalent | Benvenue Medical, Inc. | accessdata.fda.gov |
| June 17, 2020 | K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System | KWQ | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| December 19, 2019 | K190881 | Spinal Elements Navigated Instruments | OLO | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| September 16, 2019 | K191576 | Mercury® Spinal System, Overwatch® Spinal System | NKB | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| May 23, 2019 | K183560 | Luna 3D GEN2 Interbody Fusion System | MAX | Substantially Equivalent | Benvenue Medical, Inc. | accessdata.fda.gov |
| April 3, 2019 | K190289 | Karma® Fixation System | OWI | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| December 10, 2018 | K182584 | Lucent® XP | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| November 2, 2018 | K181837 | Spinal Elements Ti-Bond coated devices | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| September 6, 2018 | K180728 | Spinal Elements Cerclage System | OWI | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| April 10, 2018 | K172967 | Mercury® Spinal System | NKB | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| November 29, 2017 | K170235 | Lucent® | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| November 17, 2016 | K162431 | Luna 3D Interbody Fusion System | MAX | Substantially Equivalent | Benvenue Medical, Inc. | accessdata.fda.gov |
| November 8, 2016 | K160924 | Amendia Interbody Fusion Devices | MAX | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| October 13, 2016 | K161842 | Overwatch Spine System | NKB | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| August 1, 2016 | K153352 | Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System | OVE | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| July 28, 2016 | K160465 | Spinal Elements' Spinous Process Plate System | PEK | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| July 8, 2016 | K152920 | Savannah-T® Pedicle Screw System | NKB | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| June 9, 2016 | K152011 | Lucent Intervertebral Body Fusion Device | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| April 27, 2016 | K153152 | Syzygy Stabilization System | NKB | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| February 18, 2016 | K160291 | Optimus ALIF System | OVD | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| January 14, 2016 | K152972 | Amendia Stand-Alone Cervical System | OVE | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| January 6, 2016 | K151310 | Amendia Interbody Fusion Devices | MAX | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| December 22, 2015 | K152460 | Rectangular Corpectomy Cage | MQP | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| October 15, 2015 | K152455 | Amendia Cervical Plate System | KWQ | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| September 10, 2015 | K151322 | Amendia Interbody Fusion Devices | MAX | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| September 3, 2015 | K151705 | Lotus Posterior Cervical/Thoracic Spinal System | NKG | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| August 10, 2015 | K150395 | Omega LIF System | MAX | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| June 3, 2015 | K151215 | Mercury Spinal System | NKB | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| May 19, 2015 | K150061 | Lucent; Lucent Ti-Bond Systems | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| December 10, 2014 | K133218 | Crystal ®; Mosaic ®; Vertu ® | OVE | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| August 22, 2014 | K141372 | MERCURY SPINAL SYSTEM | NKB | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| April 11, 2014 | K132596 | PROPOSED OPTIMUS | OVD | Substantially Equivalent | Custom Spine, Inc. | accessdata.fda.gov |
| February 11, 2014 | K132925 | SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK | NKB | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| January 22, 2014 | K132122 | KESTREL POSTERIOR CERVICAL SPINE SYSTEM | KWP | Substantially Equivalent | Omni Surgical, LLC Dba Spine360 | accessdata.fda.gov |
| October 24, 2013 | K131427 | LOTUS | KWP | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| February 21, 2013 | K122967 | LUCENT | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| January 10, 2013 | K122771 | SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | OVE | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| October 17, 2012 | K122085 | STINGRAY CERVICAL CAGE | ODP | Substantially Equivalent | Omni Surgical, LP Dba Spine360 | accessdata.fda.gov |
| July 30, 2012 | K120467 | SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM | NKB | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| July 3, 2012 | K120177 | SPINAL ELEMENTS CERCLAGE SYSTEM | JDQ | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| May 23, 2012 | K110632 | LUCENT OR LUCENT MAGNUM | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| April 11, 2012 | K113533 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | HAE | Substantially Equivalent | Baxano, Inc. | accessdata.fda.gov |
| April 3, 2012 | K113361 | SECURIS SPINAL FIXATION | NKB | Substantially Equivalent | Cumtom Spine | accessdata.fda.gov |
| December 6, 2011 | K113011 | SPARTAN S3 FACET SYSTEM | MRW | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| July 20, 2011 | K111774 | PATHWAY MODEL 07XXXX | MAX | Substantially Equivalent | Custom Spine | accessdata.fda.gov |
| July 7, 2011 | K110696 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | ETN | Substantially Equivalent | Baxano, Inc. | accessdata.fda.gov |
| May 5, 2011 | K111099 | ISSYS LP SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Custom Spine, Inc. | accessdata.fda.gov |
| February 28, 2011 | K110047 | VERTICOR K-WIRE SYSTEM | HTY | Substantially Equivalent | Verticor, Ltd. | accessdata.fda.gov |
| February 2, 2011 | K102995 | TALON SPINAL SYSTEM | MNI | Substantially Equivalent | Spine360 | accessdata.fda.gov |
| January 19, 2011 | K102594 | IO-FLEX CATHETER | BSO | Substantially Equivalent | Baxano, Inc. | accessdata.fda.gov |
| January 7, 2011 | K102322 | STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF) | MAX | Substantially Equivalent | Omni Surgical, L.P. | accessdata.fda.gov |
| October 14, 2010 | K101848 | SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| July 23, 2010 | K100958 | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES | HAE | Substantially Equivalent | Baxano, Inc. | accessdata.fda.gov |
| May 19, 2010 | K101151 | REGENT ANTERIOR CERVICAL PLATE | KWQ | Substantially Equivalent | Custom Spine | accessdata.fda.gov |
| May 13, 2010 | K100265 | DIAMOND ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| February 4, 2010 | K092531 | SPINE360 ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Spine360 | accessdata.fda.gov |
| December 23, 2009 | K091426 | CERVICORE CORPECTOMY CAGE | MQP | Substantially Equivalent | Verticor, Ltd. | accessdata.fda.gov |
| November 17, 2009 | K092568 | SPARTAN S3 FACET SYSTEM | MRW | Substantially Equivalent | Amendia, Inc. | accessdata.fda.gov |
| August 17, 2009 | K091134 | CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE | KWQ | Substantially Equivalent | Custom Spine, Inc. | accessdata.fda.gov |
| July 1, 2009 | K091587 | MERCURY SPINAL SYSTEM | NKB | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| April 2, 2009 | K081770 | BLACK WIDOW ANTERIOR BUTTRESS PLATE | KWQ | Substantially Equivalent | Omni Surgical, L.P. | accessdata.fda.gov |
| February 27, 2009 | K081240 | TIGER DISCECTOMY DEVICE | HRX | Substantially Equivalent | Spinal Devices, LLC | accessdata.fda.gov |
| February 18, 2009 | K082992 | AXXION LIGHT GUIDE | FST | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| February 13, 2009 | K083475 | LUCENT MAGNUM | OVD | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| January 22, 2009 | K082353 | MERCURY SPINAL SYSTEM | NKB | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| January 13, 2009 | K083167 | PHENIX CERVICAL INTERBODY DEVICE | ODP | Substantially Equivalent | Spinal Devices, LLC | accessdata.fda.gov |
| December 3, 2008 | K083230 | MERCURY SPINAL SYSTEM | NKB | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| September 11, 2008 | K081711 | LUCENT MAGNUM+ | OVD | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| September 5, 2008 | K081614 | ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES | ODP | Substantially Equivalent | Interbody Innovations, Llp | accessdata.fda.gov |
| August 5, 2008 | K081968 | MODIFICATION TO LUCENT | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| July 14, 2008 | K081418 | SPINAL ELEMENTS BUTTRESS PLATE SYSTEM | KWQ | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| May 1, 2008 | K080281 | PATHWAY | MAX | Substantially Equivalent | Custom Spine, Inc. | accessdata.fda.gov |
| April 16, 2008 | K080058 | TURBO PRIME IBD SYSTEM | MAX | Substantially Equivalent | Spineselect, LLC | accessdata.fda.gov |
| March 20, 2008 | K072116 | SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM | NKB | Substantially Equivalent | Neurospine Innovations and Solutions | accessdata.fda.gov |
| January 24, 2008 | K073351 | CRYSTAL | ODP | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| December 26, 2007 | K073348 | LUCENT MAGNUM | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| December 13, 2007 | K072866 | ISSYS LP SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | Custom Spine, Inc. | accessdata.fda.gov |
| November 9, 2007 | K071724 | LUCENT | MAX | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| October 23, 2007 | K071833 | MOSAIC DEVICES | OVE | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| October 15, 2007 | K072029 | PHENIX VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | New Business Development, LLC | accessdata.fda.gov |
| October 12, 2007 | K071914 | MERCURY SPINAL SYSTEM | NKB | Substantially Equivalent | Spinal Elements, Inc. | accessdata.fda.gov |
| September 4, 2007 | K071824 | ACME TALON PEDICLE SCREW | MNI | Substantially Equivalent | Acme Spine, LLC | accessdata.fda.gov |
| June 11, 2007 | K070281 | ISSYS LP SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Custom Spine, Inc. | accessdata.fda.gov |
| March 13, 2006 | K060491 | QUANTUM ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Quantum Orthopedics, Inc. | accessdata.fda.gov |
| April 7, 2005 | K050377 | NBD HEAD SCREW | HAW | Substantially Equivalent | New Business Development, LLC | accessdata.fda.gov |
| January 14, 2005 | K043522 | ISSYS PEDICLE SCREW SYSTEM | KWP | Substantially Equivalent | Custom Spine, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 9, 2015 | 70950 | Class III | Terminated | 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 non-cervical spine. Ro | Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device. | accessdata.fda.gov |
| December 18, 2014 | 70044 | Class II | Terminated | 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 non-operative treatmen | Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (all revisions) the content regarding the Ti-Bond coating within the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications. | accessdata.fda.gov |
| April 17, 2009 | 53487 | Class III | Terminated | 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. | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | accessdata.fda.gov |
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Updated May 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.