FDA.reportPublic FDA data

SABER-XA, Expandable Spacer, 34x26mm, 11mm, (6°)

Primary DI
00810017916108
Brand
SABER-XA, Expandable Spacer, 34x26mm, 11mm, (6°)
Company
ELEVATION SPINE, INC.
Model
XAB-S1106
Catalog number
XAB-S1106
Device description
SABER-XA, Expandable Spacer, 34x26mm, 11mm, (6°)
Published
2026-09-29
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
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
00810017916108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017916108008100179161088100179161080810017916108

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
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)XAB-M1312XAB-M13122026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HXAP-M13XAP-M132026-10-01
00810017915668SABER-XA, Trial InserterXA-INS-TRIALXA-INS-TRIAL2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedXA-AWL-SXA-AWL-S2026-09-29
00810017916115SABER-XA, Expandable Spacer, 34x26mm, 13mm, (12°)XAB-S1312XAB-S13122026-09-29
00810017916122SABER-XA, Expandable Spacer, 34x26mm, 16mm, (18°)XAB-S1618XAB-S16182026-09-29
00810017916177SABER-XA, Expandable Spacer, 37x28mm,11mm, (6°)XAB-M1106XAB-M11062026-09-29
00810017915170SABER-XA, Screw Ø5.5 x 32.5XAS-5532XAS-55302026-09-22
00810017915118Saber-C Instrument CaseCI-CADDY-TRL12CI-CADDY-TRL122026-07-27
00810017915125SABER-XA, Screw Ø5.0 x 22.5XAS-5022XAS-50222026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5XAS-5032XAS-50322026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5XAS-5522XAS-55222026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5XAS-5527XAS-55272026-09-22
00810017915132SABER-XA, Screw Ø5.0 x 27.5XAS-5027XAS-50272026-09-21
00810017915682SABER-XA, Trial, 34x26mm, 11mm, (6°)XA-TS1106XA-TS11062026-09-21
00810017915699SABER-XA, Trial, 34x26mm, 13mm, (12°)XA-TS1312XA-TS13122026-09-21
00810017915705SABER-XA, Trial, 34x26mm, 16mm, (18°)XA-TS1618XA-TS16182026-09-21
00810017915712SABER-XA, Trial, 37x28mm, 9mm, (6°)XA-TM0906XA-TM09062026-09-21
00810017915729SABER-XA, Trial, 37x28mm,11mm, (6°)XA-TM1106XA-TM11062026-09-21
00810017915736SABER-XA, Trial, 37x28mm, 13mm, (12°)XA-TM1312XA-TM13122026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.KWQ2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.ODP2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.OVE2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.KWQ2026-10-01
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857160460CASCADIA™ Interbody SystemVB Spine LLCODP2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCODP2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19