FDA.reportPublic FDA data

Saber-C Body (PT), 14x17x7 12 deg.

Primary DI
00810017914562
Brand
Saber-C Body (PT), 14x17x7 12 deg.
Company
ELEVATION SPINE, INC.
Model
CBT-4727-P
Catalog number
CBT-4727-P
Device description
Saber-C Body (PT), 14x17x7 12 deg.
Published
2026-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body
ODPIntervertebral Fusion Device With Bone Graft, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810017914562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017914562008100179145628100179145620810017914562

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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped 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 packaged with the cage.

Contacts#

Phone, Email table
PhoneEmail
844-415-0226info@elevationspine.com

Regulatory Flags#

DUNS number
085718404
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810017914548Saber-C Body (PT), 14x17x6 12 deg.CBT-4726-PCBT-4726-P2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.CBT-4728-PCBT-4728-P2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.CBT-4729-PCBT-4729-P2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.CBT-4721-PCBT-4721-P2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.CP-4721CP-47212026-07-23
00810017916450Saber-C522-0020-12522-0020-122026-07-07
00810017916467Saber-C522-0020-14522-0020-142026-07-07
00810017916474Saber-C522-0020-16522-0020-162026-07-07
00810017916481Saber-C522-0020-18522-0020-182026-07-07
00810017916498Saber-C522-0020-20522-0020-202026-07-07
00810017913893Saber-C Body (PT), 14x17x6 6 deg.CBT-4766-PCBT-4766-P2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.CBT-4767-PCBT-4767-P2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.CBT-4768-PCBT-4768-P2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.CBT-4769-PCBT-4769-P2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.CP-2525CP-25252026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.CP-2526CP-25262026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.CP-2527CP-25272026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.CP-2528CP-25282026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.CP-2529CP-25292026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.CP-2521CP-25212026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00843511102579Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-07-23
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22