FDA.reportPublic FDA data

CoRoent

Primary DI
00887517330390
Brand
CoRoent
Company
Nuvasive, Inc.
Model
6791008
Device description
CoRoent® SI Ta Markers, 8x17x14 7° Con
Published
2015-10-24
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
ODPIntervertebral fusion device with bone graft, cervical
OVEIntervertebral fusion device with integrated fixation, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102547000
K142299000
K161442000
K170961000
K192582000
K231735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102547000COROENT INTERLOCK SYSTEMNuvasive, Inc.2011-02-07OVE
K142299000CoRoent Small Interlock SystemNu Vasive, Incorporated2014-11-25OVE
K161442000NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated2016-09-28OVE
K170961000NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated2017-06-08OVE
K192582000NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated2019-11-13OVE
K231735000NuVasive 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 SystemNu Vasive, Incorporated2023-07-11ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517330390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517330390008875173303908875173303900887517330390

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal fusion cage, non-sterileA non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. 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
00887517656582ReLine13125560131255602026-04-15
00887517377692CoRoent68510122015-10-24
00887517390516CoRoent69102452015-10-24
00195377006424CoRoent6791713P26791713P22026-05-08
00195377006431CoRoent6791712P26791712P22026-05-08
00887517051905CoRoent6791715P26791715P22026-05-08
00887517051912CoRoent6791716P26791716P22026-05-08
00887517051929CoRoent6791812P26791812P22026-05-08
00887517051936CoRoent6791813P26791813P22026-05-08
00887517051943CoRoent6791814P26791814P22026-05-08
00887517051950CoRoent6791815P26791815P22026-05-08
00887517051967CoRoent6791816P26791816P22026-05-08
00887517180513MaXcess32000282022-07-20
00887517063434MaXcess10109872019-11-21
00887517074973MaXcess10254612019-11-21
00887517183323MaXcess32001202019-11-21
00887517183378MaXcess32002202019-11-21
00887517206084MaXcess34000332019-11-21
00887517206572MaXcess34000442019-11-21
00887517497222MaXcess32410022019-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776391560CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391577CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391584CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391591CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391607CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391614CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391621CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391638CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391645CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391652CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391669CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391676CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391553CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-08
00810017916450Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017916450Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916467Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916467Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017916474Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017916474Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916481Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916481Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017916498Saber-CELEVATION SPINE, INC.ODP2026-07-07
00810017916498Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.ODP2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.OVE2026-06-25