Fixone Meniscal Repair

GUDID 08800039100830

The Fixone Meniscal Repair are all-inside meniscal repair devices. Each device includes two peek anchors, pre-tied with non-absorbable suture pre-loaded into a needle delivery system with an adjustable length depth limiter. The device is made to insert into the joint, place and fix the first anchor(T1) around the ruptured meniscus cartilage, and then place and fix the second anchor(T2) to make one Stitch to seal the torn cartilage. The device is provided sterile for single use only.

AJU PHARM. CO., LTD.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 08800039100830
• NIH Device Record Key: cc72ad32-a265-48c2-960b-af1f007f4034
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixone Meniscal Repair
• Version Model Number: FMC-14665B
• Company DUNS: 963422810
• Company Name: AJU PHARM. CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	08800039100830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233601

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, 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: 2025-01-14
• Device Publish Date: 2025-01-06

On-Brand Devices [Fixone Meniscal Repair]

• 08800039101226: The Fixone Meniscal Repair are all-inside meniscal repair devices. Each device includes two peek
• 08800039100830: The Fixone Meniscal Repair are all-inside meniscal repair devices. Each device includes two peek