FDA 510(k) Applications Submitted by NUVASIVE, INCORPORATED
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K200719 |
03/19/2020 |
NuVasive Navigation.S Instruments |
NuVasive, Incorporated |
K230894 |
03/31/2023 |
NuVasive Modulus ALIF System |
NuVasive, Incorporated |
K223181 |
10/11/2022 |
NuVasive Reline System |
NuVasive, Incorporated |
K170271 |
01/27/2017 |
NuVasive(r) Monolith Corpectomy System |
NuVasive, Incorporated |
K150474 |
02/23/2015 |
NuVasive VuePoint II OCT System |
NuVasive, Incorporated |
K140479 |
02/26/2014 |
COROENT XL-F SYSTEM |
NUVASIVE, INCORPORATED |
K170592 |
02/28/2017 |
NuVasive BASE Interfixated Titanium System |
NuVasive, Incorporated |
K170961 |
03/31/2017 |
NuVasive CoRoent Small Interlock II System |
NuVasive, Incorporated |
K140921 |
04/10/2014 |
COROENT SMALL INTERBODY SYSTEM |
NUVASIVE, INCORPORATED |
K150994 |
04/15/2015 |
NuVasive CoRoent Thoracolumbar Implants |
NUVASIVE, INCORPORATED |
K161265 |
05/05/2016 |
NuVasive« VersaTie System |
NUVASIVE, INCORPORATED |
K151214 |
05/06/2015 |
ALIF Interfixated System |
NuVasive, Incorporated |
K171633 |
06/02/2017 |
NuVasive TLX Interbody System |
NuVasive, Incorporated |
K172123 |
07/14/2017 |
NuVasive« Modulus XLIF Interbody System |
NuVasive, Incorporated |
K172341 |
08/02/2017 |
NuVasive« Modulus TLIF Interbody System |
NuVasive, Incorporated |
K142299 |
08/18/2014 |
CoRoent Small Interlock System |
NUVASIVE, INCORPORATED |
K122910 |
09/21/2012 |
ARCHON ANTERIOR CERVICAL PLATE SYSTE, |
NUVASIVE, INCORPORATED |
K173025 |
09/28/2017 |
NuVasive« MLX« û Medial Lateral Expandable Lumbar Interbody System; NuVasive« AP Expandable XLIF System |
NuVasive, Incorporated |
K143595 |
12/18/2014 |
NuVasive(R) CCX-L Interbody System |
NuVasive, Incorporated |
K173892 |
12/21/2017 |
NuVasive« XLX Interbody System |
NuVasive, Incorporated |
K163707 |
12/29/2016 |
NuVasive CoRoent Ti-C System |
NuVasive, Incorporated |
K200956 |
04/09/2020 |
NuVasive Thoracolumbar Plates |
NuVasive, Incorporated |
K201820 |
07/01/2020 |
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody |
NuVasive, Incorporated |
K112709 |
09/19/2011 |
STIMULATION/DISSECTION INSTRUMENTS |
NUVASIVE, INCORPORATED |
K231735 |
06/14/2023 |
NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System |
NuVasive, Incorporated |
K190636 |
03/12/2019 |
NuVasive« Reline« 4.5-5.0 System |
NuVasive, Incorporated |
K201078 |
04/22/2020 |
NuVasive« ACP System |
NuVasive, Incorporated |
K140563 |
03/05/2014 |
LATERAL VBR SYSTEM |
NUVASIVE, INCORPORATED |
K130820 |
03/25/2013 |
EXPANDABLE LUMBAR INTERBODY SYSTEM |
NUVASIVE, INCORPORATED |
K133530 |
11/15/2013 |
NUVASIVE EMG ENDOTRACHEAL TUBE |
NUVASIVE, INCORPORATED |
K143641 |
12/22/2014 |
NuVasive NVM5 System |
NuVasive, Incorporated |
K210271 |
02/01/2021 |
NuVasive Modulus ALIF System |
NuVasive, Incorporated |
K221751 |
06/16/2022 |
NuVasive Cohere ALIF System Intervertebral Body Fusion Device |
NuVasive, Incorporated |
K201692 |
06/22/2020 |
NuVasive Modulus XLIF Interbody System |
NuVasive, Incorporated |
K191974 |
07/24/2019 |
NuVasive AttraX Putty |
NuVasive, Incorporated |
K192582 |
09/19/2019 |
NuVasive CoRoent Small Interlock System |
NuVasive, Incorporated |
K192760 |
09/30/2019 |
NuVasive Modulus XLIF Interbody System |
NuVasive, Incorporated |
K203253 |
11/04/2020 |
NuVasive ACP System |
NuVasive, Incorporated |
K203714 |
12/21/2020 |
NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive C |
NuVasive, Incorporated |
K193593 |
12/23/2019 |
NuVasive 3DP Interfixated ALIF System |
NuVasive, Incorporated |
K181386 |
05/25/2018 |
NuVasive Brigade Lateral System |
NuVasive, Incorporated |
K191500 |
06/06/2019 |
NuVasive« ACP System |
NuVasive, Incorporated |
K190418 |
02/21/2019 |
NuVasive« VersaTie« System |
NuVasive, Incorporated |
K182974 |
10/26/2018 |
NuVasive Reline System |
NuVasive, Incorporated |
K153336 |
11/19/2015 |
VuePoint OCT System |
NUVASIVE, INCORPORATED |
K220478 |
02/18/2022 |
NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System |
NuVasive, Incorporated |
K230989 |
04/06/2023 |
Rod Registration Frame |
NuVasive, Incorporated |
K210574 |
02/26/2021 |
NuVasive Pulse System |
NuVasive, Incorporated |
K192435 |
09/05/2019 |
NuVasive NuvaLine |
NuVasive, Incorporated |
K210439 |
02/12/2021 |
NuVasive MOD-EX XLIF Interbody System |
NuVasive, Incorporated |
K170800 |
03/17/2017 |
NuVasive LessRay with Enhanced Tracking |
NuVasive, Incorporated |
K172623 |
09/01/2017 |
NuVasive Navigation Instruments |
NuVasive, Incorporated |
K173314 |
10/19/2017 |
LessRay System |
NuVasive, Incorporated |
K150362 |
02/12/2015 |
NuVasive CoRoent Small Interbody System |
NuVasive, Incorporated |
K180498 |
02/26/2018 |
NuVasive Reline Fenestrated Screws, High V+ Bone Cement |
NuVasive, Incorporated |
K180550 |
03/01/2018 |
NuVasive Monolith Cervical Corpectomy System |
NuVasive, Incorporated |
K161230 |
05/02/2016 |
NuVasive Lumbar Interbody Implants |
NUVASIVE, INCORPORATED |
K163491 |
12/12/2016 |
NuVasive CoRoent Small Interbody System |
NuVasive, Incorporated |
K153782 |
12/31/2015 |
NuVasive« Lumbar Interbody Implants |
NUVASIVE, INCORPORATED |
K151472 |
06/01/2015 |
NuVasive CoRoent Lumbar System |
NuVasive, Incorporated |
K171894 |
06/26/2017 |
NuVasive« PreceptÖ Spinal System |
NuVasive, Incorporated |
K170962 |
03/31/2017 |
NuVasive« CoRoent« Thoracolumbar System |
NuVasive, Incorporated |
K172497 |
08/18/2017 |
NuVasive AttraX Scaffold |
NuVasive, Incorporated |
K172676 |
09/05/2017 |
NuVasive« Modulus-C Interbody System |
NuVasive, Incorporated |
K160051 |
01/11/2016 |
NuVasive« Interfixated Interbody System |
NuVasive, Incorporated |
K180198 |
01/24/2018 |
NuVasive« VuePoint« II OCT System |
NuVasive, Incorporated |
K160916 |
04/01/2016 |
CoRoent« Ti-C System |
NUVASIVE, INCORPORATED |
K200953 |
04/09/2020 |
NuVasive« Cohere« Thoracolumbar Interbody System |
NuVasive, Incorporated |
K191553 |
06/12/2019 |
NuVaisve« Reline« Cervical System |
NuVasive, Incorporated |
K142050 |
07/28/2014 |
NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM |
NUVASIVE, INCORPORATED |
K162138 |
08/01/2016 |
NuVasive CoRoent Small Ti-C System |
NUVASIVE, INCORPORATED |
K173030 |
09/28/2017 |
Vertera Spine Cohere Cervical Interbody Fusion Device |
NuVasive, Incorporated |
K173153 |
09/29/2017 |
Vertera SpineÖ CoalesceÖ Thoracolumbar Interbody Fusion System |
NuVasive, Incorporated |
K143065 |
10/24/2014 |
NuVasive ALIF Buttress Plate System |
NUVASIVE, INCORPORATED |
K153419 |
11/25/2015 |
NuVasive CoRoent Thoracolumbar System |
NUVASIVE, INCORPORATED |
K193541 |
12/20/2019 |
NuVasive Cohere Thoracolumbar Interbody System |
NuVasive, Incorporated |
K180038 |
01/05/2018 |
NuVasive Pulse System |
NuVasive, Incorporated |
K170126 |
01/13/2017 |
NuVasive« Reline« 4.5-5.0 System |
NUVASIVE, INCORPORATED |
K210214 |
01/27/2021 |
NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System |
NuVasive, Incorporated |
K140659 |
03/14/2014 |
COROENT THORACOLUMBAR IMPLANTS |
NUVASIVE, INCORPORATED |
K140770 |
03/27/2014 |
MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM |
NUVASIVE, INCORPORATED |
K160989 |
04/08/2016 |
NuVasive« Reline« System |
NuVasive, Incorporated |
K151167 |
05/01/2015 |
NuVasive PEEK Corpectomy System |
NUVASIVE, INCORPORATED |
K151374 |
05/22/2015 |
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System |
NuVasive, Incorporated |
K151538 |
06/08/2015 |
NuVasive PEEK Corpectomy Railed System |
NuVasive, Incorporated |
K151651 |
06/18/2015 |
NuVasive X-CORE Mini Cervical Expandable VBR System |
NUVASIVE, INCORPORATED |
K181860 |
07/12/2018 |
NuVasive Cohere Thoracolumbar Interbody System |
NuVasive, Incorporated |
K141896 |
07/14/2014 |
COROENT SYSTEM |
NUVASIVE, INCORPORATED |
K132411 |
08/02/2013 |
AFFIX II SPINOUS PROCESS PLATE SYSTEM |
NUVASIVE, INCORPORATED |
K132601 |
08/20/2013 |
COROENT STERILE IMPLANTS SYSTEM |
NUVASIVE, INCORPORATED |
K142499 |
09/05/2014 |
Reline System |
NUVASIVE, INCORPORATED |
K162647 |
09/22/2016 |
NuVasive NuvaLine Mobile App |
NUVASIVE, INCORPORATED |
K142737 |
09/23/2014 |
MAS PLIF Fixation system |
NUVASIVE, INCORPORATED |
K172979 |
09/27/2017 |
NuVasive« Growth Rod Conversion Set |
NuVasive, Incorporated |
K153105 |
10/27/2015 |
MLXÖ - Medial Lateral Expandable Lumbar Interbody System |
NuVasive, Incorporated |
K143388 |
11/26/2014 |
Affix IIS Spinous Process Plate System |
NuVasive, Incorporated |
K143579 |
12/18/2014 |
NuVasive Sterilization Trays |
NuVasive, Incorporated |
K212446 |
08/05/2021 |
NuVasive Anterior Cervical Plate Systems |
NuVasive, Incorporated |
K221388 |
05/13/2022 |
NuVasive Reline Cervical System |
NuVasive, Incorporated |
K203201 |
10/29/2020 |
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fu |
NuVasive, Incorporated |
K213654 |
11/19/2021 |
NuVasive Reline Cervical System |
NuVasive, Incorporated |
K132694 |
08/29/2013 |
NUVASIVE NVM5 SYSTEM |
NUVASIVE, INCORPORATED |
K161014 |
04/11/2016 |
NuVasive« Reline« System |
NUVASIVE, INCORPORATED |
K191169 |
05/01/2019 |
NuVasive« Camber Laminoplasty System |
NuVasive, Incorporated |
|
|