FDA.reportPublic FDA data

X-CORE

Primary DI
00887517677969
Brand
X-CORE
Company
Nuvasive, Inc.
Model
5960011P2
Device description
X-CORE Mini Lock Screw, Endcap
Published
2020-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal vertebral body replacement device
PLTAutomated blood cell and plasma separator for cryofiltration, therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
PLTAutomated blood cell and plasma separator for cryofiltration, therapeutic

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151651000NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated2015-09-25PLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517677969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517677969008875176779698875176779690887517677969

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517127693MaXcess707042270704222026-07-27
00887517065100ACP18008223180082232026-04-25
00887517065124ACP18008312180083122026-04-25
00887517065162ACP18008316180083162026-04-25
00887517065186ACP18008318180083182026-04-25
00887517065384ACP18008512180085122026-04-25
00887517065612ACP18008622180086222026-04-25
00887517065643ACP18009117180091172026-04-25
00887517065667ACP18009119180091192026-04-25
00887517065681ACP18009121180091212026-04-25
00887517065926ACP18009229180092292026-04-25
00887517100412VuePoint897711589771152026-04-25
00887517156297ReLine11010511110105112026-04-25
00887517156822ReLine11010530110105302026-04-25
00887517378828CoRoent685121768512172026-04-25
00887517413673MAS PLIF707004270700422026-04-25
00887517645135CoRoent680050868005082026-04-25
00887517645142CoRoent680051068005102026-04-25
00887517645166CoRoent680051468005142026-04-25
00887517645173CoRoent680150868015082026-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311258635C-Plus PEEK IBF SystemXtant Medical Holdings, Inc.MQP2026-08-26
00763000858063T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-08-01
00889929072929HONOUR® Spacer SystemNEXXT SPINE, LLCMQP2026-07-29
00889929072936HONOUR® Spacer SystemNEXXT SPINE, LLCMQP2026-07-29
18257200151271CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151288CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151295CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151325CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151349CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151356CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151363CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151370CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151387CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151394CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151424CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151431CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151448CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151455CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151462CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151479CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151493CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151509CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151523CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151530CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151547CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151561CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151578CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151585CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151592CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151608CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17