Porous Wedge - Evans 10 mm NB5610

GUDID 00813909013404

Synthetic bone void filler for orthopedic applications

NOVABONE PRODUCTS, LLC

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 00813909013404
• NIH Device Record Key: f5bff65e-b512-4c75-a399-0ba5b1f6a133
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Porous Wedge - Evans 10 mm
• Version Model Number: NB5610
• Catalog Number: NB5610
• 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	00813909013404 [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

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• 00813909013671 - Wound Matrix: 2026-02-25 Collagen wound dressing
• 00813909013695 - Wound Matrix: 2026-02-25 Collagen wound dressing