FDA.reportPublic FDA data

CoRoent

Primary DI
00887517221889
Brand
CoRoent
Company
Nuvasive, Inc.
Model
6921450P
Device description
CoRoent XL-W, 14x22x50mm 10°
Published
2019-12-09
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
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081611000NUVASIVE COROENT SYSTEMNuvasive, Inc.2008-10-02ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517221889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517221889008875172218898875172218890887517221889

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
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
B084AC1141605070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141606070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141607070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141608070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141609070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141610070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141611070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141612070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161807000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161807040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161807070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161808000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161808040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161808070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161809000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161809040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161809070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161810000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161810040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161810070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161811000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161811040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161811070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161812000Anterior Cervical IBFDKEOSODP2024-02-09