3.1 mm Inion CPS® SCR-1227

GUDID 06438408001000

3.1 x 12 mm screw

Inion Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: 06438408001000
• NIH Device Record Key: 4df70578-3fbd-41bd-a8c2-46cacf0813fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.1 mm Inion CPS®
• Version Model Number: 1
• Catalog Number: SCR-1227
• 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	06438408001000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020266

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: 2023-09-04
• Device Publish Date: 2023-08-27

On-Brand Devices [3.1 mm Inion CPS®]

• 06438408011641: 3.1 x 18 mm screw
• 06438408011634: 3.1 x 16 mm screw
• 06438408011627: 3.1 x 14 mm screw
• 06438408011610: 3.1 x 12 mm screw
• 06438408011603: 3.1 x 10 mm screw
• M224SCR12309: 3.1 x 18 mm screw
• M224SCR12299: 3.1 x 16 mm screw
• M224SCR12289: 3.1 x 14 mm screw
• M224SCR12279: 3.1 x 12 mm screw
• M224SCR12269: 3.1 x 10 mm screw
• 06438408001031: 3.1 x 18 mm screw
• 06438408001024: 3.1 x 16 mm screw
• 06438408001017: 3.1 x 14 mm screw
• 06438408001000: 3.1 x 12 mm screw
• 06438408000997: 3.1 x 10 mm screw