Bi-Ostetic Bioactive Glass Foam AA1-50X10-02

GUDID 00816125023561

Bi-Ostetic Bioactive Glass Foam 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 and the 45S5 glass particles are bioactive. Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, synthetic
Primary Device ID00816125023561
NIH Device Record Keya78a061b-8d87-43aa-acb7-f289c07598e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBi-Ostetic Bioactive Glass Foam
Version Model NumberAA1-50X10-02
Catalog NumberAA1-50X10-02
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
GS100816125023561 [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 Number3
Public Version Date2019-12-23
Device Publish Date2018-08-17

On-Brand Devices [Bi-Ostetic Bioactive Glass Foam]

00816125023578Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralize
00816125023561Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralize
00816125023530Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralize
00816125023523Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralize
00816125023516Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralize
00816125023509Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralize
00816125023639Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralize
00816125023622Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralize
00816125023806Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralize
00816125023790Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralize
00816125023783Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralize
00816125024759Bi-Ostetic™ Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineral
00816125024742Bi-Ostetic™ Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineral
00816125024735Bi-Ostetic™ Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineral
00816125024728Bi-Ostetic™ Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineral

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