2.5 mm Inion OTPS™ FRF-1023

GUDID 06438408005862

4 hole plate

Inion Oy

Orthopaedic fixation plate, bioabsorbable

• Primary Device ID: 06438408005862
• NIH Device Record Key: 99898e40-b327-47e8-8e65-77aa6423bf53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.5 mm Inion OTPS™
• Version Model Number: 1
• Catalog Number: FRF-1023
• Company DUNS: 367994657
• Company Name: Inion Oy
• Device Count: 1
• DM Exempt: false
• 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	06438408005862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023887

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 [2.5 mm Inion OTPS™]

• M224FRF10419: 4 hole plate, extended long
• M224FRF10369: 10 hole plate
• M224FRF10279: 8 hole plate
• M224FRF10269: 6 hole plate, extended
• M224FRF10259: 6 hole plate
• M224FRF10249: 4 hole plate, extended
• M224FRF10239: 4 hole plate
• 06438408005961: 4 hole plate, extended long
• 06438408005916: 10 hole plate
• 06438408005909: 8 hole plate
• 06438408005893: 6 hole plate, extended
• 06438408005886: 6 hole plate
• 06438408005879: 4 hole plate, extended
• 06438408005862: 4 hole plate