Inion OTPS FreedomPlate™ FRF-1066

GUDID 06438408005718

Plate, 20 x 100 mm, concave

Inion Oy

Orthopaedic fixation plate, bioabsorbable

• Primary Device ID: 06438408005718
• NIH Device Record Key: 3eb85fae-37c8-486d-a07b-9dd656c84749
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion OTPS FreedomPlate™
• Version Model Number: 1
• Catalog Number: FRF-1066
• Company DUNS: 367994657
• Company Name: Inion Oy
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	06438408005718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063410

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 FreedomPlate™]

• M224FRF10669: Plate, 20 x 100 mm, concave
• M224FRF10659: Plate, 20 x 65 mm, concave
• M224FRF10649: Plate, 20 x 100 mm
• M224FRF10639: Plate, 20 x 65 mm
• 06438408005718: Plate, 20 x 100 mm, concave
• 06438408005701: Plate, 20 x 65 mm, concave
• 06438408005695: Plate, 20 x 100 mm
• 06438408005688: Plate, 20 x 65 mm