Bond Apatite

GUDID 07290014838031

AUGMA BIOMATERIALS LTD

Synthetic bone graft

• Primary Device ID: 07290014838031
• NIH Device Record Key: bc9c349e-c14b-49ec-9572-6ca3ead5c9d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bond Apatite
• Version Model Number: HA-BB-Pack1-NoEU
• Company DUNS: 533432352
• Company Name: AUGMA BIOMATERIALS LTD
• 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: true
• 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	07290014838031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121177

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-09
• Device Publish Date: 2020-11-17

On-Brand Devices [Bond Apatite]

• 17290014838021: Bond Apatite® is a synthetic, ‎osteoconductive, composite graft cement ‎composed of biphasi
• 07290014838130: HA-BB-LAA-NoEU
• 07290014838031: HA-BB-Pack1-NoEU
• 07290014838123: HA-BB-LAM-NoEU
• 07290014838116: HA-BB-LMM-NoEU