Inion Hexalon™ ACL/PCL Screw ACL-4113

GUDID 06438408002397

ACL/PCL screw 6 x 20 mm

Inion Oy

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• Primary Device ID: 06438408002397
• NIH Device Record Key: bfab5809-8124-4082-babc-db103cd43fda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion Hexalon™ ACL/PCL Screw
• Version Model Number: 1
• Catalog Number: ACL-4113
• 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	06438408002397 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-05
• Device Publish Date: 2022-08-26

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• 06438408002397: ACL/PCL screw 6 x 20 mm