Porous Wedge 35% NB5835

GUDID 00813909012926

Synthetic bone void filler for orthopedic applications

NOVABONE PRODUCTS, LLC

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00813909012926
• NIH Device Record Key: f0491916-8071-4740-8e82-b97efcf52f1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Porous Wedge 35%
• Version Model Number: NB5835
• Catalog Number: NB5835
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00813909012926 [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: 2024-07-18
• Device Publish Date: 2024-07-10

Devices Manufactured by NOVABONE PRODUCTS, LLC

• 00813909013107 - Bioactive Strip 5.0cc: 2024-11-26 Synthetic bone void filler for orthopedic applications
• 00813909013114 - Putty Syringe 2.5cc: 2024-11-26 Synthetic bone void filler for orthopedic applications
• 00813909013121 - Putty Syringe 5.0cc: 2024-11-26 Synthetic bone void filler for orthopedic applications
• 00813909013138 - Putty Syringe 10.0cc: 2024-11-26 Synthetic bone void filler for orthopedic applications
• 00813909013145 - IRM - 5.0cc: 2024-11-26 Synthetic bone void filler for orthopedic applications
• 00813909012988 - Dispenser MIS Cartridge: 2024-08-29 Dispenser used with synthetic bone void filler for orthopedic applications
• 00813909012995 - Putty MIS System 10.0cc: 2024-08-29 Synthetic bone void filler for orthopedic applications
• 00813909013091 - Putty MIS System 10.0cc: 2024-08-29 Synthetic bone void filler for orthopedic applications