Inion Trinion™ SET-3002

GUDID M224SET30029

10 mm (x3) meniscus screw

Inion Oy

Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw Meniscus screw 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