FDA.reportPublic FDA data

27mm x 12mm x 18mm TLIF with Inserter and Tamp

Primary DI
B064XM01127181
Brand
27mm x 12mm x 18mm TLIF with Inserter and Tamp
Company
XENCO MEDICAL LLC
Model
XM-011-2718
Device description
27mm x 12mm x 18mm TLIF
Published
2015-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B064XM01127181PrimaryHIBCC0

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. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
079282130
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B064HB1180002Sorrento Bioglass 2cc (25 x 20 x 4 mm)HB-118-00022026-04-13
B064HB1180005Sorrento Bioglass 5cc (25 x 50 x 4 mm)HB-118-00052026-04-13
B064HB1180010Sorrento Bioglass 10cc (100 x 20 x 5 mm)HB-118-00102026-04-13
B064HB1180012Sorrento Bioglass 12cc (100 x 20 x 6 mm)HB-118-00122026-04-13
B064HB1180020Sorrento Bioglass 20cc (100 x 25 x 8 mm)HB-118-00202026-04-13
B064HB1180024Sorrento Bioglass 24cc (25 x 240 x 4 mm)HB-118-00242026-04-13
B064XMTL111230823mm x 10mm x 8mm Titanium PLIF with InserterXM-TL-111-23082026-04-13
B064XMTL111230923mm x 10mm x 9mm Titanium PLIF with InserterXM-TL-111-23092026-04-13
B064XMTL111231023mm x 10mm x 10mm Titanium PLIF with InserterXM-TL-111-23102026-04-13
B064XMTL111231123mm x 10mm x 11mm Titanium PLIF with InserterXM-TL-111-23112026-04-13
B064XMTL111231223mm x 10mm x 12mm Titanium PLIF with InserterXM-TL-111-23122026-04-13
B064XMTL111231323mm x 10mm x 13mm Titanium PLIF with InserterXM-TL-111-23132026-04-13
B064XMTL111280828mm x 11mm x 8mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28082026-04-13
B064XMTL111280928mm x 11mm x 9mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28092026-04-13
B064XMTL111281028mm x 11mm x 10mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28102026-04-13
B064XMTL111281128mm x 11mm x 11mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28112026-04-13
B064XMTL111281228mm x 11mm x 12mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28122026-04-13
B064XMTL111281328mm x 11mm x 13mm Straight Titanium TLIF with Inserter and TampXM-TL-111-28132026-04-13
B064XM3D31223121CancelleX™ 13mm x 12mm x 12mm x 12* Cervical InterbodyXM-3D-312-23122026-02-06
B064XM3D31225061CancelleX™ 15mm x 13mm x 6mm x 12* Cervical InterbodyXM-3D-312-25062026-02-06