Inion Trinion™ SET-3002

GUDID M224SET30029

10 mm (x3) meniscus screw

Inion Oy

Meniscus screw

• Primary Device ID: M224SET30029
• NIH Device Record Key: 7c95309d-0b0f-46c9-9079-62314fa95e9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion Trinion™
• Version Model Number: 1
• Catalog Number: SET-3002
• 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	06438408004612 [Secondary]
HIBCC	M224SET30029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031714

FDA Product Code

• HWC: Screw, 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: 2019-06-07
• Device Publish Date: 2017-02-07

On-Brand Devices [Inion Trinion™]

• M224SET30029: 10 mm (x3) meniscus screw
• M224MRD30109: 10 mm meniscus screw