2.0 mm Inion CPS® SCR-1280

GUDID 06438408011726

2.0 x 11 mm screw

Inion Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: 06438408011726
• NIH Device Record Key: 9824a3ed-ce5f-4876-98ee-f065a79e1c09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.0 mm Inion CPS®
• Version Model Number: 1
• Catalog Number: SCR-1280
• 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	06438408011726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010352

FDA Product Code

• JEY: PLATE, 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 [2.0 mm Inion CPS®]

• M224SOP10339: 90 x 90 x 0.6 mm Solid Sheet
• M224PLT10339: Mesh plate, 14x14 holes
• M224PLT10329: Mesh plate, 7x7 holes
• 06438408011856: 2.0 x 20 mm screw (2 x)
• 06438408011849: 2.0 x 17 mm screw (2 x)
• 06438408011832: 2.0 x 15 mm screw (2 x)
• 06438408011825: 2.0 x 13 mm screw (2 x)
• 06438408011818: 2.0 x 11 mm screw (2 x)
• 06438408011801: 2.0 x 9 mm screw (2 x)
• 06438408011757: 2.0 x 17 mm screw
• 06438408011740: 2.0 x 15 mm screw
• 06438408011733: 2.0 x 13 mm screw
• 06438408011726: 2.0 x 11 mm screw
• 06438408011719: 2.0 x 9 mm screw
• 06438408011658: 2.0 x 20 mm screw
• 06438408011528: 2.0 x 7 mm screw (5 + EMGY)
• 06438408011511: 2.0 x 5 mm screw (5 + EMGY)
• 06438408011382: Mesh plate, 14x14 holes
• 06438408011375: Mesh plate, 7x7 holes
• 06438408011221: L-plate left, 7 holes
• 06438408011214: L-plate right, 7 holes
• 06438408011207: 6 hole plate
• 06438408011191: X-plate, 7 holes
• 06438408011184: 2 hole plate
• 06438408011177: H-plate, 8 holes
• 06438408011160: C-plate, 7 holes
• 06438408011153: 10 hole plate
• 06438408011146: 4 hole plate, extended
• 06438408011139: 4 hole plate
• M224SCR12899: 2.0 x 20 mm screw (2 x)
• M224SCR12889: 2.0 x 17 mm screw (2 x)
• M224SCR12879: 2.0 x 15 mm screw (2 x)
• M224SCR12869: 2.0 x 13 mm screw (2 x)
• M224SCR12859: 2.0 x 11 mm screw (2 x)
• M224SCR12849: 2.0 x 9 mm screw (2 x)
• M224SCR12839: 2.0 x 17 mm screw
• M224SCR12829: 2.0 x 15 mm screw
• M224SCR12819: 2.0 x 13 mm screw
• M224SCR12809: 2.0 x 11 mm screw
• M224SCR12799: 2.0 x 9 mm screw
• M224SCR12339: 2.0 x 20 mm screw
• M224SCR12259: 2.0 x 7 mm screw (5 + EMGY)
• M224SCR12249: 2.0 x 5 mm screw (5 + EMGY)
• M224PLT10409: L-plate left, 7 holes
• M224PLT10399: L-plate right, 7 holes
• M224PLT10389: 6 hole plate
• M224PLT10379: X-plate, 7 holes
• M224PLT10229: 2 hole plate
• M224PLT10209: H-plate, 8 holes
• M224PLT10179: C-plate, 7 holes