Inion CPS FreedomPlate™ PLT-1064

GUDID 06438408011313

Plate, 20 x 100 mm

Inion Oy

Orthopaedic fixation plate, bioabsorbable

• Primary Device ID: 06438408011313
• NIH Device Record Key: 4e914151-e854-485f-b36a-f40c7c58604f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion CPS FreedomPlate™
• Version Model Number: 1
• Catalog Number: PLT-1064
• 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	06438408011313 [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: 2022-04-12
• Device Publish Date: 2022-04-04

On-Brand Devices [Inion CPS FreedomPlate™]

• 06438408011337: Plate, 20 x 100 mm, concave
• 06438408011320: Plate, 20 x 65 mm, concave
• 06438408011313: Plate, 20 x 100 mm
• 06438408011306: Plate, 20 x 65 mm
• 06438408000720: Plate, 20 x 100 mm, concave
• 06438408000713: Plate, 20 x 65 mm, concave
• 06438408000706: Plate, 20 x 100 mm
• 06438408000690: Plate, 20 x 65 mm
• M224FRF10639I0: Plate, 20 x 65 mm