FDA.reportPublic FDA data

X-CORE

Primary DI
00887517267245
Brand
X-CORE
Company
Nuvasive, Inc.
Model
5954356
Device description
X-CORE Mini Core, Ø14mm 36-62mm
Published
2017-03-23
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
K142205000
K151651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142205000NuVasive X-CORE(R) Expandable VBR SystemNuvasive, Inc.2015-02-20MQP
K151651000NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated2015-09-25PLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517267245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517267245008875172672458875172672450887517267245

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesis, non-sterileA non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517729545TLX580126558012652026-04-25
00887517729576TLX580140258014022026-04-25
00887517729620TLX580330558033052026-04-25
00887517729644TLX580340258034022026-04-25
00887517729705TLX581126558112652026-04-25
00887517729767TLX581330558133052026-04-25
00887517729781TLX581340258134022026-04-25
00887517824912TLX179260217926022026-04-25
00887517824929TLX179260317926032026-04-25
00887517824967TLX179260717926072026-04-25
00887517825018TLX179261217926122026-04-25
00887517825025TLX179261317926132026-04-25
00887517825063TLX179261717926172026-04-25
00887517825100TLX179262117926212026-04-25
00887517825124TLX179262317926232026-04-25
00887517825162TLX179262717926272026-04-25
00887517825216TLX179263217926322026-04-25
00887517825261TLX179263717926372026-04-25
00887517825315TLX179264217926422026-04-25
00887517825322TLX179264317926432026-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
00840283403460LumiVy™VY SPINE LLCMQP2026-06-05
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00841732128231VALEO VBRCTL Medical CorporationMQP2023-09-27
00841732128248VALEO VBRCTL Medical CorporationMQP2023-09-27
07640172551103KONG-TL VBR System, Expansion Handleicotec AGMQP2020-06-19
07640172551110KONG-TL VBR System, Locking Rodicotec AGMQP2020-06-19
08033726407923DSCSINTEA PLUSTEK SRLMQP2015-10-16
08033726404250DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726404267DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407664DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407671DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407701DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407718DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407725DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407732DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407749DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407756DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407763DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407770DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407787DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407794DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407800DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407817DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407824DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407831DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407848DSCSINTEA PLUSTEK SRLMQP2015-10-09