FDA 510(k) Applications Submitted by Spinal Elements, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120177 |
01/20/2012 |
SPINAL ELEMENTS CERCLAGE SYSTEM |
SPINAL ELEMENTS, INC. |
| K120467 |
02/15/2012 |
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
| K110632 |
03/04/2011 |
LUCENT OR LUCENT MAGNUM |
SPINAL ELEMENTS, INC. |
| K131427 |
05/17/2013 |
LOTUS |
SPINAL ELEMENTS, INC. |
| K101848 |
07/01/2010 |
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM |
SPINAL ELEMENTS, INC. |
| K122771 |
09/10/2012 |
SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM |
SPINAL ELEMENTS, INC. |
| K122967 |
09/25/2012 |
LUCENT |
SPINAL ELEMENTS, INC. |
| K151705 |
06/24/2015 |
Lotus Posterior Cervical/Thoracic Spinal System |
SPINAL ELEMENTS, INC. |
| K141372 |
05/27/2014 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
| K210044 |
01/07/2021 |
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System |
Spinal Elements, Inc. |
| K201029 |
04/20/2020 |
Sapphire« Spinal System, Sapphire X Anterior Cervical Plate Spinal System |
Spinal Elements, Inc. |
| K231252 |
05/01/2023 |
VentanaÖ L Spinal System |
Spinal Elements, Inc. |
| K202298 |
08/13/2020 |
Lucent XP, Lucent XP Curved |
Spinal Elements, Inc. |
| K222516 |
08/19/2022 |
Mercury« II Spinal System |
Spinal Elements, Inc. |
| K222833 |
09/20/2022 |
VentanaÖ C Spinal System |
Spinal Elements, Inc. |
| K133218 |
10/18/2013 |
Crystal «; Mosaic «; Vertu « |
SPINAL ELEMENTS, INC. |
| K203254 |
11/04/2020 |
Lucent 3D Spinal System |
Spinal Elements, Inc. |
| K081418 |
05/20/2008 |
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM |
SPINAL ELEMENTS, INC. |
| K091587 |
06/02/2009 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
| K081711 |
06/17/2008 |
LUCENT MAGNUM+ |
SPINAL ELEMENTS, INC. |
| K071724 |
06/25/2007 |
LUCENT |
SPINAL ELEMENTS, INC. |
| K071833 |
07/03/2007 |
MOSAIC DEVICES |
SPINAL ELEMENTS, INC. |
| K081968 |
07/10/2008 |
MODIFICATION TO LUCENT |
SPINAL ELEMENTS, INC. |
| K071914 |
07/11/2007 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
| K082353 |
08/15/2008 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
| K082992 |
10/07/2008 |
AXXION LIGHT GUIDE |
SPINAL ELEMENTS, INC. |
| K083230 |
11/03/2008 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
| K083475 |
11/24/2008 |
LUCENT MAGNUM |
SPINAL ELEMENTS, INC. |
| K073348 |
11/29/2007 |
LUCENT MAGNUM |
SPINAL ELEMENTS, INC. |
| K073351 |
11/29/2007 |
CRYSTAL |
SPINAL ELEMENTS, INC. |
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