Inion Trinion instrument INS-9215

GUDID M224INS921510

Screwdriver shaft

Inion Oy

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: M224INS921510
• NIH Device Record Key: 351789fa-630d-469d-b313-20c95ba8eaf6
• Commercial Distribution Discontinuation: 2023-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Inion Trinion instrument
• Version Model Number: 1
• 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
GS1	06438408004667 [Secondary]
HIBCC	M224INS921510 [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: 8
• Public Version Date: 2023-06-30
• Device Publish Date: 2016-08-31

On-Brand Devices [Inion Trinion instrument]

• M224INS92159: Screwdriver shaft
• M224INS921510: Screwdriver shaft