Spinal Elements, Inc.
Spinal Elements, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2026, with 23 FDA device recalls on record.
Top product codes for Spinal Elements, Inc.
FDA recalls by Spinal Elements, Inc.
10 most recent of 23- Z-1597-2015 — 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. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy.
- Z-0907-2015 — 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 treatment prior to being treated with this device.
- Z-1260-2013 — 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.
- Z-1266-2013 — 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.
- Z-1247-2013 — 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.
- Z-1246-2013 — 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.
- Z-1263-2013 — 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.
- Z-1251-2013 — 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.
- Z-1261-2013 — 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.
- Z-1252-2013 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Spinal Elements, Inc.
- K260506 — Ventana® P/T Lumbar Interbody System
- K253559 — Ventana A Anterior Lumbar Interbody System
- K250773 — Luna® Ti Interbody Fusion System
- K242527 — The Karma® Fixation System
- K243916 — Primus Spinal Fixation System
- K231593 — Sapphire X3 Anterior Cervical Plate System
- K231252 — Ventana L Spinal System
- K222833 — Ventana C Spinal System
- K222516 — Mercury® II Spinal System
- K210044 — Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
- K203254 — Lucent 3D Spinal System
- K202298 — Lucent XP, Lucent XP Curved
- K201029 — Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
- K190881 — Spinal Elements Navigated Instruments
- K191576 — Mercury® Spinal System, Overwatch® Spinal System
- K190289 — Karma® Fixation System
- K182584 — Lucent® XP
- K181837 — Spinal Elements Ti-Bond coated devices
- K180728 — Spinal Elements Cerclage System
- K172967 — Mercury® Spinal System
- K170235 — Lucent®
- K153352 — Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
- K160465 — Spinal Elements' Spinous Process Plate System
- K152011 — Lucent Intervertebral Body Fusion Device
- K151705 — Lotus Posterior Cervical/Thoracic Spinal System
- K151215 — Mercury Spinal System
- K150061 — Lucent; Lucent Ti-Bond Systems
- K133218 — Crystal ®; Mosaic ®; Vertu ®
- K141372 — MERCURY SPINAL SYSTEM
- K131427 — LOTUS
- K122967 — LUCENT
- K122771 — SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
- K120467 — SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
- K120177 — SPINAL ELEMENTS CERCLAGE SYSTEM
- K110632 — LUCENT OR LUCENT MAGNUM
- K101848 — SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
- K091587 — MERCURY SPINAL SYSTEM
- K082992 — AXXION LIGHT GUIDE
- K083475 — LUCENT MAGNUM
- K082353 — MERCURY SPINAL SYSTEM
- K083230 — MERCURY SPINAL SYSTEM
- K081711 — LUCENT MAGNUM+
- K081968 — MODIFICATION TO LUCENT
- K081418 — SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
- K073351 — CRYSTAL
- K073348 — LUCENT MAGNUM
- K071724 — LUCENT
- K071833 — MOSAIC DEVICES
- K071914 — MERCURY SPINAL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.