Inion Hexalon™ SET-4000

GUDID M224SET40009

ACL/PCL screw 7x25, 8x25, 8x30, 9x30 mm

Inion Oy

Bioabsorbable orthopaedic bone screw

• Primary Device ID: M224SET40009
• NIH Device Record Key: 2a20bf32-1aba-4745-ba1e-ff0d9e75a3b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion Hexalon™
• Version Model Number: 1
• Catalog Number: SET-4000
• Company DUNS: 367994657
• Company Name: Inion Oy
• 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: false
• 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	06438408002526 [Secondary]
HIBCC	M224SET40009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071464

FDA Product Code

• JDR: Staple, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2017-02-07

Devices Manufactured by Inion Oy

• M224INS900510 - Inion instrument: 2025-06-02 1.5 mm self tapping drill bit (J-latch)
• M224INS90059 - Inion instrument: 2025-06-02 1.5 mm self tapping drill bit (J-latch)
• M224INS901310 - Inion instrument: 2025-06-02 2.0 mm self tapping drill bit (J-latch)
• M224INS90139 - Inion instrument: 2025-06-02 2.0 mm self tapping drill bit (J-latch)
• M224INS902810 - Inion instrument: 2025-06-02 2.5 mm self tapping drill bit (J-latch)
• M224INS90289 - Inion instrument: 2025-06-02 2.5 mm self tapping drill bit (J-latch)
• M224INS90359 - Inion instrument: 2025-06-02 1.5 mm self tapping drill bit (dental coupling)
• M224INS90369 - Inion instrument: 2025-06-02 2.0 mm self tapping drill bit (dental coupling)