SIGNAFUSE Bioactive Bone Graft SGFS-005

GUDID 00816986020488

SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

BIOVENTUS LLC

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• Primary Device ID: 00816986020488
• NIH Device Record Key: 5c2c3c3f-6f2a-4559-a25a-d7c8c9f19ad1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNAFUSE Bioactive Bone Graft
• Version Model Number: 25X25X8 MM, 5 CC
• Catalog Number: SGFS-005
• Company DUNS: 078450878
• Company Name: BIOVENTUS 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: false
• 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

Customer Support Contacts

• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com
• Phone: 800-637-4391
• Email: CSSurgical@bioventusglobal.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816986020488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193513

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: 2020-08-07
• Device Publish Date: 2020-07-30

On-Brand Devices [SIGNAFUSE Bioactive Bone Graft]

• 00816986020518: SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral
• 00816986020501: SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral
• 00816986020495: SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral
• 00816986020488: SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral