Porous Wedge - Cotton 5 mm NB5705

GUDID 00813909013428

Synthetic bone void filler for orthopedic applications

NOVABONE PRODUCTS, LLC

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00813909013428
• NIH Device Record Key: c0bbece1-818f-443c-b8d5-2b2f0827f5ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Porous Wedge - Cotton 5 mm
• Version Model Number: NB5705
• Catalog Number: NB5705
• Company DUNS: 828813290
• Company Name: NOVABONE PRODUCTS, 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

Device Dimensions

• 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	00813909013428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090731

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: 2025-04-17
• Device Publish Date: 2025-04-09

Devices Manufactured by NOVABONE PRODUCTS, LLC

• 00813909013329 - Dental Putty Syringe 0.5cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013336 - Dental Putty Syringe 1.0cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013343 - Dental Putty Syringe 2.0cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013350 - Dental Cartridge Dispenser: 2025-05-05 Dispenser used with synthetic bone void filler for dental applications
• 00813909013558 - Dental Putty Cartridge 2 x 0.5cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013565 - Dental Putty Cartridge 6 x 0.5cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013527 - PerioGlas - 2 x 0.5cc: 2025-05-05 Synthetic bone void filler for dental applications
• 00813909013534 - PerioGlas 6 x 0.5cc: 2025-05-05 Synthetic bone void filler for dental applications