FDA.reportPublic FDA data

X-CORE

Primary DI
00887517677907
Brand
X-CORE
Company
Nuvasive, Inc.
Model
5164014P2
Device description
X-CORE 2 Ti Endcap, 16x40mm -4° Ø16
Published
2023-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal vertebral body replacement device
PLRSpinal vertebral body replacement device - Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
PLRSpinal Vertebral Body Replacement Device - CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193506000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193506000NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated2020-02-26MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517677907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517677907008875176779078875176779070887517677907

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
Radiation 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
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517614360Propel50200012015-09-24
00887517614377Propel50200052015-09-24
00887517614384Propel50200102015-09-24
00887517939951AttraX50151102018-06-05
00887517939968AttraX50151202018-06-05
00887517939975AttraX50151302018-06-05
00887517939982AttraX50151032018-06-05
00887517939999AttraX50151042018-06-05
00887517940001AttraX50151062018-06-05
00887517940018AttraX50151012018-06-05
00887517940025AttraX50151022018-06-05
00887517970435Propel50202052018-12-20
00887517970442Propel50202059942018-12-20
00887517970459Propel50202102018-12-20
00887517970466Propel50202109942018-12-20
00887517970473Propel50203012018-12-20
00887517970480Propel50203019942018-12-20
00887517970497Propel50203052018-12-20
00887517971500Propel50203059942018-12-20
00887517971517Propel50203102018-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
10888857160460CASCADIA™ Interbody SystemVB Spine LLCPLR2018-04-16
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMQP2018-04-16
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217355CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19