OptiFuse Bi-Ostetic Foam Strip OM1-100X25-10

GUDID 00816125022113

OptiFuse is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. OptiFuse is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, composite

• Primary Device ID: 00816125022113
• NIH Device Record Key: 1166bf49-8411-44cb-a581-cd936b3f1b29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiFuse Bi-Ostetic Foam Strip
• Version Model Number: OM1-100X25-10
• Catalog Number: OM1-100X25-10
• 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	00816125022113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092046

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: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-04-08

On-Brand Devices [OptiFuse Bi-Ostetic Foam Strip]

• 00816125022113: OptiFuse is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (
• 00816125022106: OptiFuse is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (