Inion Hexalon™ ACL/PCL Screw ACL-4109

GUDID 06438408002502

ACL/PCL screw 9 x 30 mm

Inion Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: 06438408002502
• NIH Device Record Key: fbd2bed9-ec4b-4f60-9591-fb0b223bfed5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion Hexalon™ ACL/PCL Screw
• Version Model Number: 1
• Catalog Number: ACL-4109
• 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	06438408002502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071464

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: 2022-09-05
• Device Publish Date: 2022-08-26

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

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• M224ACL41089: ACL/PCL screw 9 x 25 mm
• M224ACL41079: ACL/PCL screw 9 x 20 mm
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• 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