FDA.reportPublic FDA data

SABER-XA, Screw Ø5.5 x 32.5

Primary DI
00810017915170
Brand
SABER-XA, Screw Ø5.5 x 32.5
Company
ELEVATION SPINE, INC.
Model
XAS-5532
Catalog number
XAS-5530
Device description
SABER-XA, Screw Ø5.5 x 32.5
Published
2026-09-22
Public version status
Update
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
00810017915170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017915170008100179151708100179151700810017915170

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
00810017915972T-Handle, 1/4" Sq, RatchetingXA-HNDL-TXA-HNDL-T2026-10-07
00810017915996Torque Limiting Expansion Driver Handle, 3.0NmXA-HNDL-EXPXA-HNDL-EXP2026-10-07
00810017916245SABER-XA, Expandable Spacer, 40x30mm, 11mm, (6°)XAB-L1106XAB-L11062026-10-07
00810017916252SABER-XA, Expandable Spacer, 40x30mm, 13mm, (12°)XAB-L1312XAB-L13122026-10-07
00810017916269SABER-XA, Expandable Spacer, 40x30mm, 16mm, (18°)XAB-L1618XAB-L16182026-10-07
00810017915293Saber-XA, Trial CaddyXA-CDY-TRIALXA-CDY-TRIAL2026-10-06
00810017915309SABER-XA, Screw CaddyXA-CDY-SCRXA-CDY-SCR2026-10-06
00810017915316SABER-XA, Cage & Plate Caddy, 34Wx26DXA-CDY-SXA-CDY-S2026-10-06
00810017915323SABER-XA, Cage & Plate Caddy, 37Wx28DXA-CDY-MXA-CDY-M2026-10-06
00810017915330SABER-XA, Cage & Plate Caddy, 40Wx30DXA-CDY-LXA-CDY-L2026-10-06
00810017915347SABER-XA, Spike CaddyXA-CDY-SPKXA-CDY-SPK2026-10-06
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
00810017916108SABER-XA, Expandable Spacer, 34x26mm, 11mm, (6°)XAB-S1106XAB-S11062026-09-29
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
00810017915118Saber-C Instrument CaseCI-CADDY-TRL12CI-CADDY-TRL122026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-15
00810161900817EARP, 22X40X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900824EARP, 22X40X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900831EARP, 22X45X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900848EARP, 22X45X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900855EARP, 22X45X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900862EARP, 22X45X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161900879EARP, 22X45X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901265EARP, 22X50X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901272EARP, 22X50X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901289EARP, 22X50X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901296EARP, 22X50X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810161901302EARP, 22X50X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-15
00810236520001ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520018ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520025ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520032ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520049ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520056ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520063ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520070ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520087ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520094ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520100ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520117ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520124ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520131ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520148ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520155ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520162ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10