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 ID: 00816125023561
• NIH Device Record Key: a78a061b-8d87-43aa-acb7-f289c07598e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bi-Ostetic Bioactive Glass Foam
• Version Model Number: AA1-50X10-02
• Catalog Number: AA1-50X10-02
• Company DUNS: 081067703
• Company Name: BERKELEY ADVANCED BIOMATERIALS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816125023561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170917

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-08-17

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

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