FuzeRight FR-KW-4000-S

GUDID 00840124514843

Implant Kit (Sterile)

FUSION ORTHOPEDICS, LLC

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00840124514843
• NIH Device Record Key: 0365466c-6c32-434d-b8e0-7987ab1db791
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeRight
• Version Model Number: FR-KW-4000-S
• Catalog Number: FR-KW-4000-S
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	00840124514843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170038

FDA Product Code

• LRN: Wire, Surgical

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: 2025-01-15
• Device Publish Date: 2025-01-07

On-Brand Devices [FuzeRight]

• 00840124505117: K-Wire 1.6mm
• 00840124501126: Peg and Hole Reaming Kit
• 00840124502260: Peg and Hole Reaming Kit
• 00840124511125: Peg and Hole Reaming Kit Stainless Steel
• 00840124514843: Implant Kit (Sterile)