FDA.reportPublic FDA data

Cohere

Primary DI
B14210000010140
Brand
Cohere
Company
VERTERA, INC.
Model
1000-00-1014
Device description
COHERE Cervical cage, 12x14x10MM with 7o Lordosis
Published
2016-06-20
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B14210000010140PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
078812764
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B14211000000010Cohere1100-00-00012018-11-09
B14211000000140Cohere1100-00-00142018-11-09
B14211000000160Cohere1100-00-00162018-11-09
B14211000100010Cohere1100-01-00012018-11-09
B1422000001012080COALESCE2000-00-1012082018-11-09
B1422000001014080COALESCE2000-00-1014082018-11-09
B14220000128080COALESCE2000-01-28082018-11-09
B14220000128090COALESCE2000-01-28092018-11-09
B14220000128100COALESCE2000-01-28102018-11-09
B14220000128110COALESCE2000-01-28112018-11-09
B14220000128120COALESCE2000-01-28122018-11-09
B14220000128140COALESCE2000-01-28142018-11-09
B14220000132090COALESCE2000-01-32092018-11-09
B14220000132100COALESCE2000-01-32102018-11-09
B14220000132110COALESCE2000-01-32112018-11-09
B14220000132120COALESCE2000-01-32122018-11-09
B14220000132140COALESCE2000-01-32142018-11-09
B14220000132160COALESCE2000-01-32162018-11-09
B1422000000908000COALESCE2000-00-0908002017-11-09
B1422000000908080COALESCE2000-00-0908082017-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.ODP2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCODP2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19