FDA.reportPublic FDA data

Trabexus®

Primary DI
W4146EB0003T0475
Brand
Trabexus®
Company
Vivorte, Inc
Model
3 cc
Catalog number
130703-03
Device description
Calcium compound bone void filler with DBM (3 cc), previously sold under Trabexus® EB brand name.
Published
2016-01-28
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

Product Codes#

Code, Name table
CodeName
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
W4146EB0003T0475PrimaryICCBBA0

GMDN Terms#

Term, Definition table
TermDefinition
Cadaveric-donor/synthetic mineral bone graftA sterile implantable device consisting of demineralized bone matrix (DBM) processed from cadaveric human bone (allograft) and mixed with bioabsorbable synthetic minerals (e.g., calcium phosphate), intended to fill bony voids or gaps in the skeletal system (e.g., spine, pelvis, extremities) that have been surgically or traumatically created; it may also serve as a bone graft extender. It is designed to be resorbed/remodelled and replaced by host bone during the healing process. It is typically supplied as a kit which requires mixing to form a putty-like substance prior to implantation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078400984
Device count
1
HCT/P
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868201000133Wizard CaP3 cc2021-07-29
00868201000140Wizard CaP5 cc2021-07-29
00868201000157Wizard CaP10 cc2021-07-29
W4146EB0010T0475Trabexus®10 cc130703-102016-01-28
W4146EB0005T0475Trabexus®5 cc130703-052016-01-28
00868201000164Fortera3 cc131133-03-S2020-05-14
00868201000171Fortera5 cc131133-05-S2020-05-14
00868201000188Fortera10 cc2020-05-14
00868201000102Trabexus ®3 cc131133-032015-10-19
00868201000119Trabexus ®5 cc131133-052015-10-19
00868201000126Trabexus ®10 cc131133-102015-10-19

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