Inion Trinion instrument INS-9215

GUDID M224INS92159

Screwdriver shaft

Inion Oy

Surgical screwdriver, reusable

• Primary Device ID: M224INS92159
• NIH Device Record Key: 002c097e-c527-493c-9261-20f8cc171afd
• Commercial Distribution Discontinuation: 2023-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Inion Trinion instrument
• Version Model Number: 0
• Catalog Number: INS-9215
• 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
HIBCC	M224INS92159 [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: 7
• Public Version Date: 2023-06-30
• Device Publish Date: 2016-08-31

On-Brand Devices [Inion Trinion instrument]

• M224INS92159: Screwdriver shaft
• M224INS921510: Screwdriver shaft