FDA.reportPublic FDA data

STERISPINE CC

Primary DI
03760219913153
Brand
STERISPINE CC
Company
SAFE ORTHOPAEDICS
Model
KITCCS10L
Published
2020-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K162531000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162531000STERISPINE CCSafe Orthopaedics2016-12-29OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760219913153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760219913153037602199131533760219913153

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
261875917
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760219910305STERISPINE PSKITMCL4402020-08-24
03760219912729STERISPINE PSKITMFL5302020-08-24
03760219912743STERISPINE PSKITMFL5352020-08-24
03760219912767STERISPINE PSKITMFL5402020-08-24
03760219912781STERISPINE PSKITMFL5452020-08-24
03760219912804STERISPINE PSKITMFL5502020-08-24
03760219912828STERISPINE PSKITMFL6352020-08-24
03760219912842STERISPINE PSKITMFL6402020-08-24
03760219912866STERISPINE PSKITMFL6452020-08-24
03760219912880STERISPINE PSKITMFL6502020-08-24
03760219912903STERISPINE PSKITMFL6552020-08-24
03760219912927STERISPINE PSKITMFL7352020-08-24
03760219912941STERISPINE PSKITMFL7402020-08-24
03760219912965STERISPINE PSKITMFL7452020-08-24
03760219912989STERISPINE PSKITMFL7502020-08-24
03760219913009STERISPINE PSKITMFL7552020-08-24
03760219913320STERISPINE PSKITMF7502020-08-24
03760219913344STERISPINE PSKITMF6302020-08-24
03760219913368STERISPINE PSKITMFL6302020-08-24
03760219913375STERISPINE PSKITACL4252020-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195860030421E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030438E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030445E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030452E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030506E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030537E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030551E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030568E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030575E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030582E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030599E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030605E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030612E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030674E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030704E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030728E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030742E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030766E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030780E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030803E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030810E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030827E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030834E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030841E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030858E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030889E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030896E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030919E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030926E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030964E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20