FDA.reportPublic FDA data

Brigade

Primary DI
00887517299413
Brand
Brigade
Company
Nuvasive, Inc.
Model
8555329
Device description
CoRoent XLR-F Screw, 5.5x35mm Beta
Published
2019-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal vertebral body replacement device
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100043000COROENT XLR STANDALONE SYSTEMNuvasive, Inc.2010-06-16OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517299413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517299413008875172994138875172994130887517299413

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

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
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
00840606187565Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187572Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187589Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187596Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187602Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187619Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187633Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.OVD2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMQP2019-10-31
10888857461819CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCOVD2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMQP2019-10-31
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857218772CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCOVD2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
04546540389084VBOSSStryker CorporationMQP2015-09-14
04546540389091VBOSSStryker CorporationMQP2015-09-14
04546540389107VBOSSStryker CorporationMQP2015-09-14
04546540389114VBOSSStryker CorporationMQP2015-09-14
04546540389121VBOSSStryker CorporationMQP2015-09-14
04546540389138VBOSSStryker CorporationMQP2015-09-14
04546540389145VBOSSStryker CorporationMQP2015-09-14
04546540389152VBOSSStryker CorporationMQP2015-09-14