FDA.reportPublic FDA data

Axle Interspinous Fusion System

Primary DI
M697T080010010
Brand
Axle Interspinous Fusion System
Company
Xtant Medical Holdings, Inc.
Model
T080-0100-1
Device description
Irix A 12mm Osteotome
Published
2015-10-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFIOSTEOTOME, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697T080010010Direct MarkingHIBCC0
M697T080010011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(937)847-8400orders@x-spine.com
+1(888)886-9354cs@xtantmedical.com

Regulatory Flags#

DUNS number
081224143
Device count
1
DM exempt
false
Premarket exempt
true
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
M697X07900081Silex Sacroiliac Joint Fusion SystemX079-00082026-07-08
M697X07900671Silex Sacroiliac Joint Fusion SystemX079-00672026-07-08
M697X07901121Silex Sacroiliac Joint Fusion SystemX079-01122026-07-08
M697X07901151Silex Sacroiliac Joint Fusion SystemX079-01152026-07-08
00849777014052Union DBM, 1cc11-0001-0012026-06-24
00849777014069Union DBM, 2.5cc11-0001-0022026-06-24
00849777014076Union DBM, 5cc11-0001-0052026-06-24
00849777014083Union DBM, 10cc11-0001-0102026-06-24
00810076560007BiomaXBMX-00012021-11-02
00810076560380BiomaXBMX-00022021-11-02
00810076560649BiomaXBMX-00052021-11-02
00810076560656BiomaXBMX-00102021-11-02
00810076560663BiomaXBMX-01012021-11-02
00810076560670BiomaXBMX-01022021-11-02
00810076560687BiomaXBMX-01052021-11-02
00810076560694BiomaXBMX-01102021-11-02
00840311263882Streamline OCT20-MODHANDLE20-MODHANDLE2026-06-04
00840311244874Streamline MIS Spinal Fixation System04-55-PR-10004-55-PR-1002026-06-03
00840311244881Streamline MIS Spinal Fixation System04-55-PR-11004-55-PR-1102026-06-03
00840311244904Streamline MIS Spinal Fixation System04-55-PR-13004-55-PR-1302026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395384MillenniumAvalign Technologies, Inc.GFI2026-07-13
10381780408567Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408574Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408581Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408680Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408703Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408710Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408727Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408734Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408741Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408758Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408765Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408772Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780188087Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188094Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188100Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188117Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188124Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188131Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188148Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188155Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188162Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188179Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188186Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188193Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188209Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188216Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188223Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188230Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188346Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02