FDA 510(k) Applications Submitted by JULIE LAMOTHE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K150061 |
01/13/2015 |
Lucent; Lucent Ti-Bond Systems |
Spinal Elements Inc. |
| K170235 |
01/25/2017 |
Lucent« |
Spinal Elements Inc. |
| K190289 |
02/11/2019 |
Karma« Fixation System |
Spinal Elements Inc |
| K160465 |
02/19/2016 |
Spinal Elements' Spinous Process Plate System |
Spinal Elements Inc. |
| K250827 |
03/18/2025 |
aprevo« anterior lumbar interbody fusion device; aprevo« lateral lumbar interbody fusion device; aprevo« anterior lumbar interbody fusion device with interfixation; aprevo« transforaminal lumbar interbody fusion device; aprevo« TLIF-CA Articulating System |
Carlsmed, Inc. |
| K180728 |
03/20/2018 |
Spinal Elements Cerclage System |
Spinal Elements Inc |
| K190881 |
04/04/2019 |
Spinal Elements Navigated Instruments |
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. |
| K151215 |
05/06/2015 |
Mercury Spinal System |
Spinal Elements Inc. |
| K231593 |
06/01/2023 |
Sapphire X3 Anterior Cervical Plate System |
Spinal Elements, Inc |
| K191576 |
06/14/2019 |
Mercury« Spinal System, Overwatch« Spinal System |
Spinal Elements, Inc |
| K181837 |
07/10/2018 |
Spinal Elements Ti-Bond coated devices |
Spinal Elements Inc. |
| K152011 |
07/21/2015 |
Lucent Intervertebral Body Fusion Device |
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. |
| K172967 |
09/26/2017 |
Mercury« 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. |
| K234150 |
12/29/2023 |
Lucent« XP |
Spinal Elements |
| K134045 |
12/31/2013 |
ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM |
ZIMMER DENTAL INC. |
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