Inion OTPS™ FRF-1061

GUDID 06438408005619

Volar Radius Plate, small

Inion Oy

Orthopaedic fixation plate, bioabsorbable

• Primary Device ID: 06438408005619
• NIH Device Record Key: 7129d862-bdca-4cfe-8622-acf5313738da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion OTPS™
• Version Model Number: 1
• Catalog Number: FRF-1061
• 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	06438408005619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052624

FDA Product Code

• HRS: Plate, 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: 2023-10-09
• Device Publish Date: 2023-09-29

On-Brand Devices [Inion OTPS™]

• M224MSH10359: Mesh plate, 14x14 holes
• M224MSH10349: Mesh plate, 7x7 holes
• M224MSH10339: Mesh plate, 14x14 holes
• M224MSH10329: Mesh plate, 7x7 holes
• M224FRF10619: Volar Radius Plate, small
• M224FRF10609: Volar Radius Plate, large
• 06438408005770: Mesh plate, 14x14 holes
• 06438408005763: Mesh plate, 7x7 holes
• 06438408005756: Mesh plate, 14x14 holes
• 06438408005749: Mesh plate, 7x7 holes
• 06438408005619: Volar Radius Plate, small
• 06438408005602: Volar Radius Plate, large