Inion CPS™ Baby SCR-1220

GUDID 06438408010927

1.5 x 4 mm screw (5+EMGY)

Inion Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: 06438408010927
• NIH Device Record Key: 3d898d1f-052a-4173-99f8-bdcd2b4d9425
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion CPS™ Baby
• Version Model Number: 1
• Catalog Number: SCR-1220
• 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	06438408010927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010351

FDA Product Code

• HWC: Screw, 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™ Baby]

• 06438408010927: 1.5 x 4 mm screw (5+EMGY)
• M224SCR12209: 1.5 x 4 mm screw (5+EMGY)
• 06438408000133: 1.5 x 4 mm screw (5+EMGY)