This page includes the latest FDA filings for Spinal Elements Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3004893332 |
| FEI Number | 3004893332 |
| Name | SPINAL ELEMENTS, INC. |
| Owner & Operator | Spinal Elements |
| Contact Address | 3115 Melrose Dr Suite 200 Carlsbad CA 92010 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 3115 Melrose Dr Suite 200 CARLSBAD, CA 92010 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| SPINAL ELEMENTS, INC. | Katana | 2025-05-29 |
| SPINAL ELEMENTS, INC. | Katana | 2025-05-29 |
| SPINAL ELEMENTS, INC. | Overwatch | 2025-05-22 |
| SPINAL ELEMENTS, INC. | LOTUS | 2025-05-05 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-05-02 |
| SPINAL ELEMENTS, INC. | Karma | 2025-03-13 |
| SPINAL ELEMENTS, INC. | Karma | 2025-03-13 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2025-02-05 |
| SPINAL ELEMENTS, INC. | Lucent XP | 2024-12-19 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-11-21 |
| SPINAL ELEMENTS, INC. | Lucent | 2024-10-30 |
| SPINAL ELEMENTS, INC. | Lucent XP | 2024-10-18 |
| SPINAL ELEMENTS, INC. | Lucent XP | 2024-10-18 |
| SPINAL ELEMENTS, INC. | Lucent XP | 2024-09-19 |
| SPINAL ELEMENTS, INC. | Lucent XP | 2024-09-19 |
| SPINAL ELEMENTS, INC. | Lucent XP | 2024-09-19 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2024-08-21 |
| SPINAL ELEMENTS, INC. | Lucent Lateral | 2024-08-21 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-06-26 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-06-26 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-06-26 |
| SPINAL ELEMENTS, INC. | MAGNUM+ | 2024-06-14 |
| SPINAL ELEMENTS, INC. | Ventana C | 2024-06-11 |
| SPINAL ELEMENTS, INC. | Ventana C | 2024-06-11 |
| SPINAL ELEMENTS, INC. | Crystal | 2024-06-11 |
| SPINAL ELEMENTS, INC. | Crystal | 2024-06-11 |
| SPINAL ELEMENTS, INC. | Crystal | 2024-06-11 |
| SPINAL ELEMENTS, INC. | Crystal | 2024-06-11 |
| SPINAL ELEMENTS, INC. | Crystal | 2024-06-11 |
| SPINAL ELEMENTS, INC. | Crystal | 2024-06-11 |
| SPINAL ELEMENTS, INC. | Crystal | 2024-06-11 |
| SPINAL ELEMENTS, INC. | Crystal | 2024-06-11 |
| SPINAL ELEMENTS, INC. | Crystal | 2024-06-11 |
| SPINAL ELEMENTS, INC. | Lotus | 2024-05-28 |
| SPINAL ELEMENTS, INC. | Multiple | 2024-05-17 |
| SPINAL ELEMENTS, INC. | Magnum + | 2024-05-02 |
| SPINAL ELEMENTS, INC. | Magnum + | 2024-05-02 |
| SPINAL ELEMENTS, INC. | Magnum + | 2024-05-02 |
| SPINAL ELEMENTS, INC. | Magnum + | 2024-05-02 |
| SPINAL ELEMENTS, INC. | Magnum + | 2024-05-02 |
| SPINAL ELEMENTS, INC. | Magnum + | 2024-05-02 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-03-13 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-03-13 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-03-13 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-03-13 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-03-13 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-03-13 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-03-13 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-03-13 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-03-13 |
| SPINAL ELEMENTS, INC. | Overwatch | 2024-03-13 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
| SPINAL ELEMENTS, INC. | Ventana L | 2024-02-14 |
Spinal Elements, Inc. | Mercury® II Spinal System | 2022-12-01 |
Spinal Elements, Inc. | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System | 2021-06-30 |
Spinal Elements, Inc. | Lucent 3D Spinal System | 2021-03-26 |
Spinal Elements, Inc. | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System | 2020-06-17 |
Spinal Elements Inc | Spinal Elements Navigated Instruments | 2019-12-19 |
Spinal Elements, Inc | Mercury® Spinal System, Overwatch® Spinal System | 2019-09-16 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Karma? Fixation System | 2019-04-04 |
Spinal Elements Inc | Karma® Fixation System | 2019-04-03 |
Spinal Elements Inc | Lucent® XP | 2018-12-10 |
Spinal Elements Inc. | Spinal Elements Ti-Bond Coated Devices | 2018-11-02 |
Spinal Elements Inc | Spinal Elements Cerclage System | 2018-09-06 |
Spinal Elements Inc. | Mercury® Spinal System | 2018-04-10 |
Spinal Elements Inc. | Lucent® | 2017-11-29 |
Spinal Elements Inc. | Vertu® & Vertu® Ti-Bond And Crystal® & Crystal® Ti-Bond Cervical Interbody System | 2016-08-01 |
Spinal Elements Inc. | Spinal Elements' Spinous Process Plate System | 2016-07-28 |
Spinal Elements Inc. | Lucent Intervertebral Body Fusion Device | 2016-06-09 |
SPINAL ELEMENTS, INC. | Lotus Posterior Cervical/Thoracic Spinal System | 2015-09-03 |
Spinal Elements Inc. | Mercury Spinal System | 2015-06-03 |
Spinal Elements Inc. | Lucent; Lucent Ti-Bond Systems | 2015-05-19 |
SPINAL ELEMENTS, INC. | Crystal ®; Mosaic ®; Vertu ® | 2014-12-10 |
SPINAL ELEMENTS, INC. | MERCURY SPINAL SYSTEM | 2014-08-22 |
SPINAL ELEMENTS, INC. | LOTUS | 2013-10-24 |
SPINAL ELEMENTS, INC. | LUCENT | 2013-02-21 |
SPINAL ELEMENTS, INC. | SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | 2013-01-10 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Wrench | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Tulip Positioner | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Tulip Adjuster | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Trial | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Trephine | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Tower Clip | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Temporary Fixation Screw | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Temporary Fixation Pin | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Tap | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Tamp | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Tab Extender | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Tab Cutter | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Tab Breaker | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Suction Tube | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Stabilizer | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Spacer | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Sleeve | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Sizer | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Set Screw Starter | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Screwdriver | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Screw Adjuster | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Rongeur | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Rod Template | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Rod Holder | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Rod Gripper | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Rod Bender | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Rocker | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Retractor | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Retainer | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Removal Tool | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Reducer | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Rasp | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Pusher | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Probe | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Post Remover | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Plate Shaver | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Plate Holder | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Plate Bender | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Pin Inserter | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Persuader | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Pedicle Marker | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Pedicle Feeler | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Packing Block | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Osteotome | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Nerver Root Retractor | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Nerve Sheild | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Marquise MIS Channel | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Lodestar | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Inserter | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Hex Retainer | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Hex Driver | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Hex Adapter | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Handle | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Hammer | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Guide | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Guide Wire | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Graft Block | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Funnel | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Elevator | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Ejector | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Dual Stylet Needle | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Drill | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Distractor | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Distraction Pin | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Distraction Pin Driver | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Disc Shaver | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Disc Shaper | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Disc Cutter | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Dilator | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Depth Tool | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Depth Sounder | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Curette | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Crown | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Crow Foot | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Counter Torque | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Compressor | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Compressor Fulcrum | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Compactor | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Cobb | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Chisel | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Cannula | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Caliper | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Broach | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Box Chisel | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Awl | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Adaptor | 2012-10-26 |
SPINAL ELEMENTS, INC. [Spinal Elements] | Access Portal | 2012-10-26 |
SPINAL ELEMENTS, INC. | SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM | 2012-07-30 |
SPINAL ELEMENTS, INC. | SPINAL ELEMENTS CERCLAGE SYSTEM | 2012-07-03 |
SPINAL ELEMENTS, INC. | LUCENT OR LUCENT MAGNUM | 2012-05-23 |
SPINAL ELEMENTS, INC. | SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM | 2010-10-14 |
SPINAL ELEMENTS, INC. | MERCURY SPINAL SYSTEM | 2009-07-01 |
SPINAL ELEMENTS, INC. | AXXION LIGHT GUIDE | 2009-02-18 |
SPINAL ELEMENTS, INC. | LUCENT MAGNUM | 2009-02-13 |
SPINAL ELEMENTS, INC. | MERCURY SPINAL SYSTEM | 2009-01-22 |
SPINAL ELEMENTS, INC. | MERCURY SPINAL SYSTEM | 2008-12-03 |
SPINAL ELEMENTS, INC. | LUCENT MAGNUM+ | 2008-09-11 |
SPINAL ELEMENTS, INC. | MODIFICATION TO LUCENT | 2008-08-05 |
SPINAL ELEMENTS, INC. | SPINAL ELEMENTS BUTTRESS PLATE SYSTEM | 2008-07-14 |
SPINAL ELEMENTS, INC. | CRYSTAL | 2008-01-24 |
SPINAL ELEMENTS, INC. | LUCENT MAGNUM | 2007-12-26 |
SPINAL ELEMENTS, INC. | LUCENT | 2007-11-09 |
SPINAL ELEMENTS, INC. | MOSAIC DEVICES | 2007-10-23 |
SPINAL ELEMENTS, INC. | MERCURY SPINAL SYSTEM | 2007-10-12 |
| NCAGE Code | 4RYR9 | SPINAL ELEMENTS, INC. |
| CAGE Code | 4RYR9 | SPINAL ELEMENTS, INC. |
| S.A.M. Registration | 4RYR9 [610712213] | SPINAL ELEMENTS, INC. |