Inion CPS™ Baby SCR-1220

GUDID M224SCR12209

1.5 x 4 mm screw (5+EMGY)

Inion Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: M224SCR12209
• NIH Device Record Key: 85106514-95bb-4ed7-94e2-58a285a1b329
• Commercial Distribution Discontinuation: 2026-01-01
• 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
HIBCC	M224SCR12209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010351

FDA Product Code

• JEY: PLATE, BONE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-08-28
• Device Publish Date: 2017-02-07

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)