FDA.reportPublic FDA data

NUVASIVE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20319663002980729NUVASIVE, INC.1N2026-01-017475 Lusk Blvd SAN DIEGO CA US 92121
30061790463006179046NuVasive Specialized Orthopedics, Inc.1N2026-01-012560 General Armistead Ave VALLEY FORGE BUSINESS CENTER Audubon PA US 19403
30091449153009144915NUVASIVE, INC.1N2026-01-01City View Plaza 1 Suites 116 & 117 #48 Rd 165 Km 1.2 Guaynabo PR US 00968
30059491513005949151NUVASIVE, INC.1N2020-04-254670 E. SHELBY DR. MEMPHIS TN US 38118
30134913273013491327NUVASIVE, INC.1N2020-04-25805 Liberty Lane -- West Carrollton OH US 45449

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00195377006424CoRoent - CoRoent SI Screw, 4x13mm Self-Tap+1(800)475-9131nuvainfo@globusmedical.com
00195377006431CoRoent - CoRoent SI Screw, 4x12mm Self-Tap+1(800)475-9131nuvainfo@globusmedical.com
00887517051905CoRoent - CoRoent SI Screw, 4x15mm Self-Tap+1(800)475-9131nuvainfo@globusmedical.com
00887517051912CoRoent - CoRoent SI Screw, 4x16mm Self-Tap+1(800)475-9131nuvainfo@globusmedical.com
00887517051929CoRoent - CoRoent SI Screw, 4.5x12mm Rescue+1(800)475-9131nuvainfo@globusmedical.com
00887517051936CoRoent - CoRoent SI Screw, 4.5x13mm Rescue+1(800)475-9131nuvainfo@globusmedical.com
00887517377692CoRoent - CoRoent® LO, 10x10x35mm 5°+1800-475-9131nuvainfo@globusmedical.com
00887517390516CoRoent - CoRoent® XL Wide, 10x22x45mm+1800-475-9131nuvainfo@globusmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
558041319220468P200022Simplify® Cervical Artificial DiscMJO2020-09-18
1322161319220468P200022Simplify® Cervical Artificial DiscMJO2020-09-18
558041153313665P100012NUVASIVE PCM CERVICAL DISC SYSTEMMJO2012-10-26
558051153313665P100012NUVASIVE PCM CERVICAL DISC SYSTEMMJO2012-10-26
558041000880082K811820BIPOLAR COAGULATING FORCEPSGEI1981-07-28
558051000880082K811820BIPOLAR COAGULATING FORCEPSGEI1981-07-28
1322161000880082K811820BIPOLAR COAGULATING FORCEPSGEI1981-07-28
558041771901428K240507NuVasive AttraX ScaffoldMQV2024-03-20
1322161771901428K240507NuVasive AttraX ScaffoldMQV2024-03-20
558041658160474K233706Bendini Cloud ApplicationOLO2024-08-02
1322161658160474K233706Bendini Cloud ApplicationOLO2024-08-02
1322161962853593K233593MAGEC Spinal Bracing and Distraction SystemPGN2024-02-06
1931161962853593K233593MAGEC Spinal Bracing and Distraction SystemPGN2024-02-06
558041561607381K231735NuVasive 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 SystemODP2023-07-11
1322161561607381K231735NuVasive 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 SystemODP2023-07-11
558041823616963K230989Rod Registration FrameOLO2023-05-05
1322161823616963K230989Rod Registration FrameOLO2023-05-05
558041885243236K230894NuVasive Modulus ALIF SystemOVD2023-06-16
1322161885243236K230894NuVasive Modulus ALIF SystemOVD2023-06-16
1322161099836037K230765Precice Ankle Salvage SystemHSB2023-08-29
1931161099836037K230765Precice Ankle Salvage SystemHSB2023-08-29
558041482260661K223731NuVasive Modulus-C Interbody SystemODP2023-01-12
1322161482260661K223731NuVasive Modulus-C Interbody SystemODP2023-01-12
558041041790983K223181NuVasive Reline SystemNKB2023-01-11
1322161041790983K223181NuVasive Reline SystemNKB2023-01-11
558041317158763K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceOVD2022-10-21
1322161317158763K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceOVD2022-10-21
558041743328696K221388NuVasive Reline Cervical SystemNKG2022-09-09
1322161743328696K221388NuVasive Reline Cervical SystemNKG2022-09-09
558041909376940K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemMAX2022-06-21
1322161909376940K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemMAX2022-06-21
1322161438917951K220234Precice Intramedullary Limb Lengthening SystemHSB2023-03-15
1931161438917951K220234Precice Intramedullary Limb Lengthening SystemHSB2023-03-15
558042033303090K213654NuVasive Reline Cervical SystemNKG2022-02-23
1322162033303090K213654NuVasive Reline Cervical SystemNKG2022-02-23
558041816659556K212446NuVasive Anterior Cervical Plate SystemsKWQ2021-11-03
1322161816659556K212446NuVasive Anterior Cervical Plate SystemsKWQ2021-11-03
558041015911645K211757Simplify DiscQLQ2021-08-20
1322161015911645K211757Simplify DiscQLQ2021-08-20
558042017416154K210574NuVasive Pulse SystemOLO2021-07-29
1322162017416154K210574NuVasive Pulse SystemOLO2021-07-29
558041495769873K210439NuVasive MOD-EX XLIF Interbody SystemMAX2021-05-12
1322161495769873K210439NuVasive MOD-EX XLIF Interbody SystemMAX2021-05-12
558042050039235K210271NuVasive Modulus ALIF SystemOVD2021-03-01
1322162050039235K210271NuVasive Modulus ALIF SystemOVD2021-03-01
558041948072718K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemMAX2021-05-24
1322161948072718K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemMAX2021-05-24
558042053957015K203714NuVasive 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 Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax PuttyMAX2021-12-23
1322162053957015K203714NuVasive 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 Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax PuttyMAX2021-12-23
558041795739269K203253NuVasive ACP SystemKWQ2020-12-03
1322161795739269K203253NuVasive ACP SystemKWQ2020-12-03
558041324065675K203201NuVasive 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 Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF SystemMAX2021-01-12
1322161324065675K203201NuVasive 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 Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF SystemMAX2021-01-12
1322161197629062K202348External Remote Controller ERC 4PHSB2020-12-22
1931161197629062K202348External Remote Controller ERC 4PHSB2020-12-22
558041814168298K201820NuVasive 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 Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF SystemMAX2020-09-25
1322161814168298K201820NuVasive 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 Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF SystemMAX2020-09-25
558041587932683K201692NuVasive Modulus XLIF Interbody SystemMAX2020-10-29
1322161587932683K201692NuVasive Modulus XLIF Interbody SystemMAX2020-10-29
1322161856531165K201567Precice® Bone Transport SystemHSB2020-08-10
1931161856531165K201567Precice® Bone Transport SystemHSB2020-08-10
1322161404435707K201543MAGEC® SystemPGN2020-07-30
1931161404435707K201543MAGEC® SystemPGN2020-07-30
558041681435127K201078NuVasive® ACP SystemKWQ2020-05-20
1322161681435127K201078NuVasive® ACP SystemKWQ2020-05-20
558041032559275K200956NuVasive Thoracolumbar PlatesKWQ2020-05-21
1322161032559275K200956NuVasive Thoracolumbar PlatesKWQ2020-05-21
558041717820436K200953NuVasive® Cohere® Thoracolumbar Interbody SystemMAX2020-10-06
1322161717820436K200953NuVasive® Cohere® Thoracolumbar Interbody SystemMAX2020-10-06
558041827240559K200719NuVasive Navigation.S InstrumentsOLO2020-12-02
1322161827240559K200719NuVasive Navigation.S InstrumentsOLO2020-12-02
1322161200203656K200430Precice® Ankle Salvage SystemHSB2020-09-16
1931161200203656K200430Precice® Ankle Salvage SystemHSB2020-09-16
1322161897173810K193617Precice® ScrewsHSB2020-05-08
1931161897173810K193617Precice® ScrewsHSB2020-05-08
558041802058148K193593NuVasive 3DP Interfixated ALIF SystemOVD2020-03-25
558051802058148K193593NuVasive 3DP Interfixated ALIF SystemOVD2020-03-25
1322161802058148K193593NuVasive 3DP Interfixated ALIF SystemOVD2020-03-25
2129421802058148K193593NuVasive 3DP Interfixated ALIF SystemOVD2020-03-25
558041244733566K193541NuVasive Cohere Thoracolumbar Interbody SystemMAX2020-03-30
558051244733566K193541NuVasive Cohere Thoracolumbar Interbody SystemMAX2020-03-30
1322161244733566K193541NuVasive Cohere Thoracolumbar Interbody SystemMAX2020-03-30
2129421244733566K193541NuVasive Cohere Thoracolumbar Interbody SystemMAX2020-03-30
558041663421533K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemMQP2020-02-26
558051663421533K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemMQP2020-02-26
1322161663421533K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemMQP2020-02-26
2129421663421533K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemMQP2020-02-26
1322161230499600K193016PRECICE Bone Transport SystemHSB2020-05-08
1931161230499600K193016PRECICE Bone Transport SystemHSB2020-05-08
558041288684868K192760NuVasive Modulus XLIF Interbody SystemMAX2019-10-18
558051288684868K192760NuVasive Modulus XLIF Interbody SystemMAX2019-10-18
1322161288684868K192760NuVasive Modulus XLIF Interbody SystemMAX2019-10-18
2129421288684868K192760NuVasive Modulus XLIF Interbody SystemMAX2019-10-18
558041939052028K192582NuVasive CoRoent Small Interlock SystemOVE2019-11-13
558051939052028K192582NuVasive CoRoent Small Interlock SystemOVE2019-11-13
1322161939052028K192582NuVasive CoRoent Small Interlock SystemOVE2019-11-13
2129421939052028K192582NuVasive CoRoent Small Interlock SystemOVE2019-11-13
558041142891441K192435NuVasive NuvaLineLLZ2019-09-26
558051142891441K192435NuVasive NuvaLineLLZ2019-09-26
1322161142891441K192435NuVasive NuvaLineLLZ2019-09-26
2129421142891441K192435NuVasive NuvaLineLLZ2019-09-26
1322161433441066K192181PRECICE Plating SystemKTT2019-11-07
1931161433441066K192181PRECICE Plating SystemKTT2019-11-07
558041291871861K191974NuVasive AttraX PuttyMQV2019-11-03
558051291871861K191974NuVasive AttraX PuttyMQV2019-11-03
1322161291871861K191974NuVasive AttraX PuttyMQV2019-11-03
2129421291871861K191974NuVasive AttraX PuttyMQV2019-11-03
558041455020060K191553NuVaisve® Reline® Cervical SystemNKG2019-08-14
558051455020060K191553NuVaisve® Reline® Cervical SystemNKG2019-08-14
1322161455020060K191553NuVaisve® Reline® Cervical SystemNKG2019-08-14
2129421455020060K191553NuVaisve® Reline® Cervical SystemNKG2019-08-14
558041515922950K191500NuVasive® ACP SystemKWQ2019-09-03
558051515922950K191500NuVasive® ACP SystemKWQ2019-09-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX1272022-06-21
HSB902023-08-29
KWQ792021-11-03
NKB592023-01-11
OVD442023-06-16
ODP372023-07-11
MQP362020-02-26
MQV282024-03-20
PGN282024-02-06
OLO222024-08-02
ETN222012-04-13
PDQ212017-03-16
NKG202022-09-09
OVE182019-11-13
OWB142017-11-16
MNH142006-09-01
OWI132019-03-21
PEK122015-03-05
GWF122010-05-14
LLZ92019-09-26
NQW82019-07-03
PLR82018-11-20
MRW82010-07-15
KCT72016-01-25
KWP62010-06-23
FTL62009-01-15
PML52018-11-28
PGM52017-11-06
FST42004-10-26
PHM32015-06-17
MNI32007-08-06
BXM32001-10-16
GEI31981-07-28
QLQ22021-08-20
MJO 22020-09-18
KTT22019-11-07
MJO22012-10-26

PMA#

PMN#

200 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next