FDA.reportPublic FDA data

CoRoent

Primary DI
00887517640802
Brand
CoRoent
Company
Nuvasive, Inc.
Model
5195357
Device description
CoRoent Ant TLIF Trial 11x14x30mm 15°
Published
2018-09-17
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
MAXIntervertebral fusion device with bone graft, lumbar
PHMIntervertebral fusion device with bone graft, thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170962000NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017-06-26MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517640802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517640802008875176408028875176408020887517640802

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable 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
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
M719GLL100QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL101QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL106QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL107QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
08800043913099N/ATDM Co., Ltd.MAX2026-06-10
08800043913105N/ATDM Co., Ltd.MAX2026-06-10
08800043913112N/ATDM Co., Ltd.MAX2026-06-10
08800043913129N/ATDM Co., Ltd.MAX2026-06-10
08800043913136N/ATDM Co., Ltd.MAX2026-06-10
08800043913143N/ATDM Co., Ltd.MAX2026-06-10
08800043913150N/ATDM Co., Ltd.MAX2026-06-10
08800043913167N/ATDM Co., Ltd.MAX2026-06-10
08800043913174N/ATDM Co., Ltd.MAX2026-06-10
08800043913181N/ATDM Co., Ltd.MAX2026-06-10
08800043913198N/ATDM Co., Ltd.MAX2026-06-10
08800043913204N/ATDM Co., Ltd.MAX2026-06-10
08800043913211N/ATDM Co., Ltd.MAX2026-06-10
08800043917288N/ATDM Co., Ltd.MAX2026-06-10
08800043917295N/ATDM Co., Ltd.MAX2026-06-10
00887517729545TLXNuvasive, Inc.MAX2026-04-25
00887517729576TLXNuvasive, Inc.MAX2026-04-25
00887517729620TLXNuvasive, Inc.MAX2026-04-25
00887517729644TLXNuvasive, Inc.MAX2026-04-25
00887517729705TLXNuvasive, Inc.MAX2026-04-25
00887517729767TLXNuvasive, Inc.MAX2026-04-25
00887517729781TLXNuvasive, Inc.MAX2026-04-25
00887517824912TLXNuvasive, Inc.MAX2026-04-25
00887517824912TLXNuvasive, Inc.PHM2026-04-25
00887517824929TLXNuvasive, Inc.PHM2026-04-25
00887517824929TLXNuvasive, Inc.MAX2026-04-25