Synthetic Backfill Bioimplant Ø6.5 x 40mm MSBG6540

GUDID 00816125024704

The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatite (HA) and tri-calcium phosphate (TCP) granules, along with 45S5 bioactive glass granules. This implant utilizes biocompatible bovine fibrillar collagen and bioactive 45S5 glass particles. The granular composition includes 60 wt% HA and 40 wt% TCP, with the graft containing 20 wt% of 45S5 granules. This device serves as a scaffold to facilitate new bone growth. A sequence of surface reactions on the granules leads to the creation of a calcium phosphate layer that closely mimics the composition and structure of bone mineral hydroxyapatite. This layer, along with the HA-TCP granules, forms an osteoconductive scaffold that supports the growth of the patient’s new bone. As healing progresses, the graft material is gradually absorbed and transformed into new bone.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00816125024704
• NIH Device Record Key: 7cd0374d-b233-4b65-b90d-9c07850f1fa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synthetic Backfill Bioimplant Ø6.5 x 40mm
• Version Model Number: MSBG6540
• Catalog Number: MSBG6540
• 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	00816125024704 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-02
• Device Publish Date: 2024-04-24

Devices Manufactured by BERKELEY ADVANCED BIOMATERIALS, LLC

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• 00816125024827 - AlexiFuse Synthetic Foam Strip: 2024-12-02 AlexiFuse Synthetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 4