Inion Hexalon™ ACL/PCL Screw ACL-4105

GUDID M224ACL41059

ACL/PCL screw 8 x 25 mm

Inion Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: M224ACL41059
• NIH Device Record Key: 04108647-28f0-4134-83c5-2aae152737d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion Hexalon™ ACL/PCL Screw
• Version Model Number: 1
• Catalog Number: ACL-4105
• Company DUNS: 367994657
• Company Name: Inion Oy
• 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: 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	06438408002465 [Secondary]
HIBCC	M224ACL41059 [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: 2019-09-30
• Device Publish Date: 2017-02-07

On-Brand Devices [Inion Hexalon™ ACL/PCL Screw]

• M224ACL41149: ACL/PCL screw 6 x 25 mm
• M224ACL41139: ACL/PCL screw 6 x 20 mm
• M224ACL41129: ACL/PCL screw 10 x 30 mm
• M224ACL41099: ACL/PCL screw 9 x 30 mm
• M224ACL41089: ACL/PCL screw 9 x 25 mm
• M224ACL41079: ACL/PCL screw 9 x 20 mm
• M224ACL41069: ACL/PCL screw 8 x 30 mm
• M224ACL41059: ACL/PCL screw 8 x 25 mm
• M224ACL41049: ACL/PCL screw 8 x 20 mm
• M224ACL41039: ACL/PCL screw 7 x 30 mm
• M224ACL41029: ACL/PCL screw 7 x 25 mm
• M224ACL41019: ACL/PCL screw 7 x 20 mm
• M224ACL41159: ACL/PCL screw 6 x 30 mm
• 06438408002519: ACL/PCL screw 10 x 30 mm
• 06438408002502: ACL/PCL screw 9 x 30 mm
• 06438408002496: ACL/PCL screw 9 x 25 mm
• 06438408002489: ACL/PCL screw 9 x 20 mm
• 06438408002472: ACL/PCL screw 8 x 30 mm
• 06438408002465: ACL/PCL screw 8 x 25 mm
• 06438408002458: ACL/PCL screw 8 x 20 mm
• 06438408002441: ACL/PCL screw 7 x 30 mm
• 06438408002434: ACL/PCL screw 7 x 25 mm
• 06438408002427: ACL/PCL screw 7 x 20 mm
• 06438408002410: ACL/PCL screw 6 x 30 mm
• 06438408002403: ACL/PCL screw 6 x 25 mm
• 06438408002397: ACL/PCL screw 6 x 20 mm