FDA.reportPublic FDA data

Xsert Lumbar Expandable Interbody System

Primary DI
M697T09204500
Brand
Xsert Lumbar Expandable Interbody System
Company
X-SPINE SYSTEMS, INC.
Model
T092-0450
Device description
Inserter Driver
Published
2017-04-01
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
HXXSCREWDRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697T09204500Direct MarkingHIBCC0
M697T09204501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and 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

Regulatory Flags#

DUNS number
610042587
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
M697C07800240H-Graft Interspinous AllograftC078-00242021-05-19
M697C07902610Silex Sacroiliac Joint Fusion SystemC079-02612021-05-19
M697C07902620Silex Sacroiliac Joint Fusion SystemC079-02622021-05-19
M697C01000880Fortex Pedicle Screw SystemC010-00882021-04-30
M697C00300090Calix Spinal Implant SystemC003-00092016-08-30
M697C00300260Calix Spinal Implant SystemC003-00262018-01-10
M697C00300270Calix Spinal Implant SystemC003-00272018-01-10
M697C00300280Calix Spinal Implant SystemC003-00282018-01-10
M697C00300290Calix Spinal Implant SystemC003-00292018-01-10
M697C00300300Calix Spinal Implant SystemC003-00302018-01-10
M697C00300310Calix Spinal Implant SystemC003-00312018-01-10
M697C00300320Calix Spinal Implant SystemC003-00322018-01-10
M697C00300330Calix Spinal Implant SystemC003-00332018-01-10
M697C00300340Calix Spinal Implant SystemC003-00342017-05-05
M697C00300350Calix Spinal Implant SystemC003-00352017-05-05
M697C00300360Calix Spinal Implant SystemC003-00362017-05-05
M697C00300370Calix Spinal Implant SystemC003-00372017-05-05
M697C00300380Calix Spinal Implant SystemC003-00382017-05-05
M697C00300390Calix Spinal Implant SystemC003-00392017-05-05
M697C00300400Calix Spinal Implant SystemC003-00402017-05-05

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08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
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
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164751MI (Mini Incision) Driver - RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164768MI (Mini Incision) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164775O (Turbine OP) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151650172.9 Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165024Vector Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151651235.5 Knotless DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165130Screw DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165178Simple Driver (Black)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165185Simple Driver (Orange)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165208Tendonesis Chamfer ReamerSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165284Staple ShaftSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
G791CDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
G791SDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
09120125220037Shark Screw® couplingsurgebright GmbHHXX2025-09-16
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08800071006848Surgical InstrumentOSTEONIC CO.,Ltd.HXX2025-06-24
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