FDA.reportPublic FDA data

Axle Interspinous Fusion System

Primary DI
M697X06003201
Brand
Axle Interspinous Fusion System
Company
Xtant Medical Holdings, Inc.
Model
X060-0320
Device description
Screwdriver, Axle System
Published
2015-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXSCREWDRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X06003200Direct MarkingHIBCC0
M697X06003201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar interspinous decompression instrument set, reusableA collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(937)847-8400orders@x-spine.com

Regulatory Flags#

DUNS number
081224143
Device count
1
Premarket exempt
true
Lot or batch
true
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
00199150081882Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-10
00199150081899Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-10
00842188132513Tools - ScrewsTrimed, INC.HXX2026-07-09
00842188132520Tools - ScrewsTrimed, INC.HXX2026-07-09
06974940307878endophixSuzhou Endophix Co., Ltd.HXX2026-06-23
008401944961003P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944963773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944966433P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944969193P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
00889024707726SolidLok®Biomet Orthopedics, LLCHXX2026-06-10
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08800322708224Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758175Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758267Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758274Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
04719879398700Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-11-26
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
04719962169132Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-10-31
04719962169224Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-10-31
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10