2.8 mm Inion CPS® SCR-1298

GUDID 06438408001345

2.8 x 12 mm screw (2 x)

Inion Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: 06438408001345
• NIH Device Record Key: 932b5913-464a-4206-a53f-bcf9250a8c44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.8 mm Inion CPS®
• Version Model Number: 1
• Catalog Number: SCR-1298
• 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	06438408001345 [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 [2.8 mm Inion CPS®]

• 06438408011993: 2.8 x 23 mm screw (2 x)
• 06438408011986: 2.8 x 18 mm screw (2 x)
• 06438408011979: 2.8 x 16 mm screw (2 x)
• 06438408011962: 2.8 x 14 mm screw (2 x)
• 06438408011955: 2.8 x 12 mm screw (2 x)
• 06438408011948: 2.8 x 10 mm screw (2 x)
• 06438408011597: 2.8 x 18 mm screw
• 06438408011580: 2.8 x 16 mm screw
• 06438408011573: 2.8 x 14 mm screw
• 06438408011566: 2.8 x 12 mm screw
• 06438408011559: 2.8 x 10 mm screw
• 06438408011542: 2.8 x 23 mm screw
• M224SCR13029: 2.8 x 23 mm screw (2 x)
• M224SCR13019: 2.8 x 18 mm screw (2 x)
• M224SCR13009: 2.8 x 16 mm screw (2 x)
• M224SCR12999: 2.8 x 14 mm screw (2 x)
• M224SCR12989: 2.8 x 12 mm screw (2 x)
• M224SCR12979: 2.8 x 10 mm screw (2 x)
• M224SCR12169: 2.8 x 18 mm screw
• M224SCR12159: 2.8 x 16 mm screw
• M224SCR12149: 2.8 x 14 mm screw
• M224SCR12139: 2.8 x 12 mm screw
• M224SCR12129: 2.8 x 10 mm screw
• M224SCR12099: 2.8 x 23 mm screw
• 06438408001383: 2.8 x 23 mm screw (2 x)
• 06438408001376: 2.8 x 18 mm screw (2 x)
• 06438408001369: 2.8 x 16 mm screw (2 x)
• 06438408001352: 2.8 x 14 mm screw (2 x)
• 06438408001345: 2.8 x 12 mm screw (2 x)
• 06438408001338: 2.8 x 10 mm screw (2 x)
• 06438408000980: 2.8 x 18 mm screw
• 06438408000973: 2.8 x 16 mm screw
• 06438408000966: 2.8 x 14 mm screw
• 06438408000959: 2.8 x 12 mm screw
• 06438408000942: 2.8 x 10 mm screw
• 06438408000935: 2.8 x 23 mm screw