NanoFuse Bioactive Matrix - 2.0 cc NAN109-02

GUDID 00858686006003

Synthetic bone void filler containing DBM for orthopedic applications

AMEND SURGICAL, INC.

Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft Cadaveric-donor/synthetic mineral bone graft

• Primary Device ID: 00858686006003
• NIH Device Record Key: 42eb59ff-f153-4b75-9904-f9c78d3c0279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoFuse Bioactive Matrix - 2.0 cc
• Version Model Number: NAN109-02
• Catalog Number: NAN109-02
• Company DUNS: 080131031
• Company Name: AMEND SURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858686006003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142104

FDA Product Code

• MBP: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

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: 2018-07-06
• Device Publish Date: 2016-08-12

Devices Manufactured by AMEND SURGICAL, INC.

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• 00858686006096 - NanoFUSE Bioactive Strip: 2019-07-24 Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantation
• 00858686006003 - NanoFuse Bioactive Matrix - 2.0 cc: 2018-07-06Synthetic bone void filler containing DBM for orthopedic applications
• 00858686006003 - NanoFuse Bioactive Matrix - 2.0 cc: 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications
• 00858686006010 - NanoFuse Bioactive Matrix - 5.0 cc: 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications
• 00858686006027 - NanoFuse Bioactive Matrix - 10.0 cc: 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications
• 00858686006034 - NanoFuse Bioactive Matrix - 1.0 cc: 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser
• 00858686006041 - Bio V BP Bioactive Glass with DBM Putty: 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser
• 00858686006058 - Bio V BP Bioactive Glass with DBM Putty - 2.0 cc: 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser