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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606168533SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168557SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
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00840606168588SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
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00840606168618SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168625SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168632SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168656SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168663SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168687SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168694SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168717SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168748SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168755SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168779SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168786SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168809SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168816SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168830SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168847SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168861SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168878SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168892SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168908SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168922SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168939SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606169769SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606169776SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27