FDA.reportPublic FDA data

SABER-XA, Trial, 34x26mm, 16mm, (18°)

Primary DI
00810017915705
Brand
SABER-XA, Trial, 34x26mm, 16mm, (18°)
Company
ELEVATION SPINE, INC.
Model
XA-TS1618
Catalog number
XA-TS1618
Device description
SABER-XA, Trial, 34x26mm, 16mm, (18°)
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810017915705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017915705008100179157058100179157050810017915705

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

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
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
00810017915170SABER-XA, Screw Ø5.5 x 32.5XAS-5532XAS-55302026-09-22
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
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
00810017915743SABER-XA, Trial, 37x28mm, 16mm, (18°)XA-TM1618XA-TM16182026-09-21
00810017915767SABER-XA, Trial, 40x30mm, 11mm, (6°)XA-TL1106XA-TL11062026-09-21
00810017915774SABER-XA, Trial, 40x30mm, 13mm, (12°)XA-TL1312XA-TL13122026-09-21
00810017915781SABER-XA, Trial, 40x30mm, 16mm, (18°)XA-TL1618XA-TL16182026-09-21
00810017915828SABER-XA, Simultaneous ExpanderXA-EXP-HLXA-EXP-HL2026-09-21
00810017915835SABER-XA, Spike Driver, InterbodyXA-DRV-SPK-IXA-DRV-SPK-I2026-09-21
00810017915842SABER-XA, TampXA-TAMPXA-TAMP2026-09-21
00810017915859SABER-XA, Inserter Knob Wrench/DriverXA-WRENCHXA-WRENCH2026-09-21
00810017915866SABER-XA, Spike Driver, PlateXA-DRV-SPK-PXA-DRV-SPK-P2026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
00840606174923PrimusSPINAL ELEMENTS, INC.LXH2026-09-22
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685231490Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685283430Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7682460370Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-09-24
B7682440010Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-06-20
B7682459240Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-05-30
B7682460080Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-05-30
B7682459260Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B768345211500Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685118310Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685211080Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685215150Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27
B7685271430Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-03-27