FDA.reportPublic FDA data

CancelleX™ 15mm x 13mm x 8mm x 12* Cervical Interbody

Primary DI
B064XM3D31225081
Brand
CancelleX™ 15mm x 13mm x 8mm x 12* Cervical Interbody
Company
XENCO MEDICAL LLC
Model
XM-3D-312-2508
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B064XM3D31225081PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
8582021505sales@xencomedical.com

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.ODP2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.ODP2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.ODP2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.ODP2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.ODP2026-06-05
08809986491008BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491015BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491022BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491039BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491046BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491053BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491060BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491077BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491084BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491091BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491107BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
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08809986491121BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986491138BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-04
08809986490742BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490759BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490766BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490773BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490780BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490797BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490803BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490810BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03