GENIE Bio Knotless Anchor

GUDID 08800298539228

4.75mm Bio anchor

OSTEONIC CO.,Ltd.

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 08800298539228
• NIH Device Record Key: 454fff83-2d05-4949-b08e-c05df5d1cb89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENIE Bio Knotless Anchor
• Version Model Number: 475BCBC
• Company DUNS: 688999370
• Company Name: OSTEONIC CO.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800298539228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243467

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

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: 2025-02-14
• Device Publish Date: 2025-02-06

On-Brand Devices [GENIE Bio Knotless Anchor]

• 08800298539235: 5.5mm Bio anchor
• 08800298539228: 4.75mm Bio anchor