FDA.reportPublic FDA data

12 Trabeculex™ Bio-inspired Matrix 10cm x 2cm x .6cm (12cc)

Primary DI
B064XM11300121
Brand
12 Trabeculex™ Bio-inspired Matrix 10cm x 2cm x .6cm (12cc)
Company
XENCO MEDICAL LLC
Model
XM-113-0012
Published
2025-11-08
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
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B064XM11300121PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, animal-derived, bioabsorbableA sterile bioabsorbable device made primarily of animal-derived bone matrix (e.g., bovine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
858-202-1505sarahdo@xencomedical.com

Regulatory Flags#

DUNS number
079282130
Device count
1
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
B064XMPHC1640202Ø4.0mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-40202026-07-28
B064XMPHC1640222Ø4.0mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-40222026-07-28
B064XMPHC1640242Ø4.0mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-40242026-07-28
B064XMPHC1645202Ø4.5mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-45202026-07-28
B064XMPHC1645222Ø4.5mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-45222026-07-28
B064XMPHC1645242Ø4.5mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXM-PH-C16-45242026-07-28
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

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ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
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