FDA.reportPublic FDA data

CERES-C

Primary DI
00840916139483
Brand
CERES-C
Company
SPINAL ELEMENTS
Model
08-171-0810
Device description
Ceres-C Spacer 12X17.5, 8 deg
Published
2021-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916139483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916139483008409161394838409161394830840916139483

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004022104
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840916161842ZEUS-L101272021-04-09
00840916161859ZEUS-L18-10402021-04-09
00840916161866ZEUS-L05-10-32021-04-09
00840916150693SAVANNAHSP-0264-6.52020-04-29
00840916161989DIAMOND70012022-03-03
00840916161996DIAMOND100112022-03-03
00840916162009DIAMOND100162022-03-03
00840916162023DIAMOND10013-102022-03-03
00840916162030DIAMOND10013-122022-03-03
00840916162047DIAMOND10013-142022-03-03
00840916162054DIAMOND10013-162022-03-03
00840916162061DIAMOND10013-182022-03-03
00840916162078DIAMOND10014-402022-03-03
00840916162085DIAMOND10021-B2022-03-03
00840916162092DIAMOND10025-2-F-B2022-03-03
00840916162108DIAMOND10025-2-V-B2022-03-03
00840916162115DIAMOND100402022-03-03
00840916162122DIAMOND100432022-03-03
00840916162139DIAMOND100472022-03-03
00840916162146DIAMOND100482022-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810056992743aprevoCarlsmed, Inc.OVE2026-03-17
00810056992804aprevoCarlsmed, Inc.OVE2026-03-17
00810056992866aprevoCarlsmed, Inc.OVE2026-03-17
00810056992958aprevoCarlsmed, Inc.OVE2026-03-17
00763000880422Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.OVE2026-03-02
10195860030407E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030414E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030469E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030476E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030483E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030490E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030513E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030520E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030544E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030629E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030636E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030643E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030650E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030667E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030681E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030698E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030711E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030735E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030759E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030773E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030797E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030865E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030872E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030902E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030933E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20