FDA.reportPublic FDA data

SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°)

Primary DI
00810017916191
Brand
SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°)
Company
ELEVATION SPINE, INC.
Model
XAB-M1618
Catalog number
XAB-M1618
Device description
SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°)
Published
2026-10-27
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
false

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810017916191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017916191008100179161918100179161910810017916191

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
false
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
00810017913763Saber-C Body (PT), 14x15x5 6 deg.CBT-4565-PCBT-4565-P2026-10-26
00810017913770Saber-C Body (PT), 14x15x6 6 deg.CBT-4566-PCBT-4566-P2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.CBT-4567-PCBT-4567-P2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.CBT-4568-PCBT-4568-P2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.CBT-4569-PCBT-4569-P2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.CBT-4561-PCBT-4561-P2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.CBT-4595-PCBT-4595-P2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.CBT-4761-PCBT-4761-P2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.CBT-4795-PCBT-4795-P2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.CBT-4796-PCBT-4796-P2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.CBT-4797-PCBT-4797-P2026-10-26
00810017913978Saber-C Body (PT), 14x17x8 9 deg.CBT-4798-PCBT-4798-P2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.CBT-4799-PCBT-4799-P2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.CBT-4791-PCBT-4791-P2026-10-26
00810017914005Saber-C Body (PT), 15x18x5 6 deg.CBT-5865-PCBT-5865-P2026-10-26
00810017914012Saber-C Body (PT), 15x18x6 6 deg.CBT-5866-PCBT-5866-P2026-10-26
00810017914029Saber-C Body (PT), 15x18x7 6 deg.CBT-5867-PCBT-5867-P2026-10-26
00810017914036Saber-C Body (PT), 15x18x8 6 deg.CBT-5868-PCBT-5868-P2026-10-26
00810017914043Saber-C Body (PT), 15x18x9 6 deg.CBT-5869-PCBT-5869-P2026-10-26
00810017914050Saber-C Body (PT), 15x18x10 6 deg.CBT-5861-PCBT-5861-P2026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809974869284Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809885799977Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809885799984Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809885799991Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779934Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779941Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779958Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779965Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779972Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779989Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974779996Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789957Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789964Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789971Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789988Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974789995Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799864Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799871Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799888Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799895Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799901Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799918Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799925Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799932Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799949Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799956Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799963Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799970Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799987Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18
08809974799994Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-18