2.5 mm Inion CPS® SCR-1241

GUDID 06438408001079

2.5 x 14 mm screw

Inion Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: 06438408001079
• NIH Device Record Key: c0546b30-cc33-475d-b46d-b6d1857ff931
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.5 mm Inion CPS®
• Version Model Number: 1
• Catalog Number: SCR-1241
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438408001079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010352

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 [2.5 mm Inion CPS®]

• M224PLT10359: Mesh plate, 14x14 holes
• M224PLT10349: Mesh plate, 7x7 holes
• 06438408011931: 2.5 x 23 mm screw (2 x)
• 06438408011924: 2.5 x 18 mm screw (2 x)
• 06438408011917: 2.5 x 16 mm screw (2 x)
• 06438408011900: 2.5 x 14 mm screw (2 x)
• 06438408011894: 2.5 x 12 mm screw (2 x)
• 06438408011887: 2.5 x 10 mm screw (2 x)
• 06438408011870: 2.5 x 8 mm screw
• 06438408011863: 2.5 x 6 mm screw
• 06438408011702: 2.5 x 18 mm screw
• 06438408011696: 2.5 x 16 mm screw
• 06438408011689: 2.5 x 14 mm screw
• 06438408011672: 2.5 x 12 mm screw
• 06438408011665: 2.5 x 10 mm screw
• 06438408011535: 2.5 x 23 mm screw
• 06438408011481: 2.5 x 8 mm screw (5 x)
• 06438408011474: 2.5 x 6 mm screw (5 x)
• 06438408011405: Mesh plate, 14x14 holes
• 06438408011399: Mesh plate, 7x7 holes
• 06438408011290: 4 hole plate, extended long
• 06438408011283: 10 hole plate
• 06438408011276: 8 hole plate
• 06438408011269: 6 hole plate, extended
• 06438408011252: 6 hole plate
• 06438408011245: 4 hole plate, extended
• 06438408011238: 4 hole plate
• M224SCR22079: 2.5 x 8 mm screw
• M224SCR22069: 2.5 x 6 mm screw
• M224SCR12959: 2.5 x 23 mm screw (2 x)
• M224SCR12949: 2.5 x 18 mm screw (2 x)
• M224SCR12919: 2.5 x 12 mm screw (2 x)
• M224SCR12909: 2.5 x 10 mm screw (2 x)
• M224SCR12439: 2.5 x 18 mm screw
• M224SCR12429: 2.5 x 16 mm screw
• M224SCR12419: 2.5 x 14 mm screw
• M224SCR12409: 2.5 x 12 mm screw
• M224SCR12399: 2.5 x 10 mm screw
• M224SCR12089: 2.5 x 23 mm screw
• M224SCR12079: 2.5 x 8 mm screw (5 x)
• M224SCR12069: 2.5 x 6 mm screw (5 x)
• M224PLT10419: 4 hole plate, extended long
• M224PLT10369: 10 hole plate
• M224PLT10279: 8 hole plate
• M224PLT10269: 6 hole plate, extended
• M224PLT10259: 6 hole plate
• M224PLT10249: 4 hole plate, extended
• M224PLT10239: 4 hole plate
• M224SCR12939: 2.5 x 16 mm screw (2 x)
• M224SCR12929: 2.5 x 14 mm screw (2 x)