FDA.reportPublic FDA data

SABER-XA, Screw Ø5.0 x 27.5

Primary DI
00810017915132
Brand
SABER-XA, Screw Ø5.0 x 27.5
Company
ELEVATION SPINE, INC.
Model
XAS-5027
Catalog number
XAS-5027
Device description
SABER-XA, Screw Ø5.0 x 27.5
Published
2026-09-21
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
00810017915132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017915132008100179151328100179151320810017915132

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
00810017915170SABER-XA, Screw Ø5.5 x 32.5XAS-5532XAS-55302026-09-22

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
00810216329235ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329242ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329259ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329266ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329273ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329280ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329297ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329303ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329310ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329334ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329341ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329358ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329372ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329389ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329396ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329402ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329419ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
B084AC1141605070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141606070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141607070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141608070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141609070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141610070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141611070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141612070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806000Anterior Cervical IBFDKEOSODP2024-02-09