FDA.reportPublic FDA data

CoRoent

Primary DI
00887517812889
Brand
CoRoent
Company
Nuvasive, Inc.
Model
6771610CP2
Device description
Interlock II Ti-C, 16x17x14mm 10°
Published
2018-01-18
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
OVEIntervertebral fusion device with integrated fixation, cervical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170961000NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated2017-06-08OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517812889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517812889008875178128898875178128890887517812889

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA 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) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00887517729071MaXcess35000172019-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.OVE2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.OVE2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.OVE2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.OVE2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.OVE2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.OVE2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.OVE2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.OVE2026-06-05
00810017913657Saber-C Body (PT), 12x15x6 6 deg.ELEVATION SPINE, INC.OVE2026-06-01
M711511410070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511410120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511411070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511411120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511412070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511412120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511606070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511607070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511607120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511608070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511608120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511609070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511609120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511610070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511610120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511611070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511611120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511612070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511612120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511806070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511807070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31