FDA.reportPublic FDA data

Saber-C Body (PT), 14x17x8 12 deg.

Primary DI
00810017914555
Brand
Saber-C Body (PT), 14x17x8 12 deg.
Company
ELEVATION SPINE, INC.
Model
CBT-4728-P
Catalog number
CBT-4728-P
Device description
Saber-C Body (PT), 14x17x8 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
00810017914555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017914555008100179145558100179145550810017914555

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
00810017913695Saber-C Body (PT), 12x15x10 6 deg.CBT-2561-PCBT-2561-P2026-08-14
00810017915804SABER-XA, Height ExpanderXA-EXP-HXA-EXP-H2026-08-14
00810017915811SABER-XA, Lordosis ExpanderXA-EXP-LXA-EXP-L2026-08-14
00810017915958Slap HammerXA-SLAPXA-SLAP2026-08-14
00810017915965Slap Hammer AdaptorXA-SLAP-AXA-SLAP-A2026-08-14
00810017915118Saber-C Instrument CaseCI-CADDY-TRL12CI-CADDY-TRL122026-07-27
00810017914548Saber-C Body (PT), 14x17x6 12 deg.CBT-4726-PCBT-4726-P2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.CBT-4727-PCBT-4727-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-09-20
00763000891480CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-09-20
08800322776391QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
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08800322776421QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776438QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776445QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776452QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776469QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776476QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776483QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776490QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776506QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776513QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776520QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776537QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776544QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776551QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776568QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776575QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776582QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776599QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776605QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776612QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776629QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776636QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776643QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776650QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776667QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18