Tribio™ Implant, 7.5mm x 40mm M80 SB008

GUDID 00816125023653

Tribio™ Implant is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible. The 45S5 glass particles are bioactive. The device is available in the form of granules, strips, and putty. The composition of the granules is 60 wt% HA and 40 wt% TCP. The amount of 45S5 granules in the graft is 20 wt%. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer on the 45S5 granules and hydroxyapatite-tri-calcium phosphate granules provide an osteoconductive scaffold onto which the patient’s new bone will grow. During healing, the graft particulate is absorbed and remodeled into new bone.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, synthetic
Primary Device ID00816125023653
NIH Device Record Key9e0d3b71-fa12-46d9-b5e3-402ff8ce0b35
Commercial Distribution StatusIn Commercial Distribution
Brand NameTribio™ Implant, 7.5mm x 40mm
Version Model NumberM80 SB008
Catalog NumberM80 SB008
Company DUNS081067703
Company NameBERKELEY ADVANCED BIOMATERIALS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816125023653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2019-05-16

Devices Manufactured by BERKELEY ADVANCED BIOMATERIALS, LLC

00816125024704 - Synthetic Backfill Bioimplant Ø6.5 x 40mm2024-05-02 The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatit
00816125024711 - Synthetic Backfill Bioimplant Ø8.5 x 40mm2024-05-02 The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatit
00816125024353 - Putty Convenience Kit, 2.5cc2023-09-05 The Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads.
00816125023875 - OptiFuse BA Moldable Matrix2022-11-24 OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri
00816125023882 - OptiFuse BA Moldable Matrix2022-11-24 OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri
00816125023899 - OptiFuse BA Moldable Matrix2022-11-24 OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri
00816125023905 - OptiFuse BA Moldable Matrix2022-11-24 OptiFuse BA® Moldable Matrix is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri
00816125023783 - Bi-Ostetic Bioactive Glass Foam2020-09-02 Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – t

Trademark Results [Tribio]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRIBIO
TRIBIO
97792603 not registered Live/Pending
Productos Alimenticios Doria S.A.S.
2023-02-13
TRIBIO
TRIBIO
88379871 not registered Live/Pending
In2Bones USA, LLC
2019-04-10
TRIBIO
TRIBIO
85612265 4389093 Live/Registered
DAI-ICHI KOGYO SEIYAKU CO., LTD.
2012-04-30
TRIBIO
TRIBIO
79279789 not registered Live/Pending
RONDONSHOES, COMÉRCIO INTERNACIONAL DE CALÇADO, LDA.
2020-01-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.