1.5 mm Inion CPS® Baby PLT-1002

GUDID M224PLT10029

C-plate, 7 holes

Inion Oy

Orthopaedic fixation plate, bioabsorbable

• Primary Device ID: M224PLT10029
• NIH Device Record Key: a4ffde8a-2b02-4e5f-8ea7-291b3c75ba20
• Commercial Distribution Discontinuation: 2026-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5 mm Inion CPS® Baby
• Version Model Number: 1
• Catalog Number: PLT-1002
• 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	M224PLT10029 [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 [1.5 mm Inion CPS® Baby]

• 06438408000102: Mesh plate, 14x14 holes
• 06438408000096: Mesh plate, 7x7 holes
• 06438408011771: 1.5 x 6 mm screw
• 06438408011764: 1.5 x 4 mm screw
• 06438408011344: 40 hole plate
• 06438408010958: 1.5 x 6 mm screw
• 06438408010941: 1.5 x 4 mm screw
• 06438408010934: 1.5 x 6 mm screw (5 + EMGY)
• 06438408010897: Mesh plate, 14x14 holes
• 06438408010880: Mesh plate, 7x7 holes
• 06438408010873: X-plate, large
• 06438408010866: 64 hole plate
• 06438408010859: 2 hole plate
• 06438408010842: X-plate, 7 holes
• 06438408010835: C-plate, 7 holes
• 06438408010828: 20 hole plate
• 06438408010811: 4 hole plate
• M224SCR22239: 1.5 x 6 mm screw
• M224SCR22229: 1.5 x 4 mm screw
• M224SCR22219: 1.5 x 6 mm screw
• M224SCR22209: 1.5 x 4 mm screw
• M224SCR12219: 1.5 x 6 mm screw (5 + EMGY)
• M224PLT10629: X-plate, large
• M224PLT10599: 64 hole plate
• M224PLT10589: 40 hole plate
• M224PLT10299: Mesh plate, 14x14 holes
• M224PLT10289: Mesh plate, 7x7 holes
• M224PLT10049: 2 hole plate
• M224PLT10039: X-plate, 7 holes
• M224PLT10029: C-plate, 7 holes
• M224PLT10019: 20 hole plate
• M224PLT10009: 4 hole plate
• 06438408001161: 1.5 x 6 mm screw
• 06438408001154: 1.5 x 4 mm screw
• 06438408000737: 40 hole plate
• 06438408000164: 1.5 x 6 mm screw
• 06438408000157: 1.5 x 4 mm screw
• 06438408000140: 1.5 x 6 mm screw (5 + EMGY)
• 06438408000089: X-plate, large
• 06438408000072: 64 hole plate
• 06438408000065: 2 hole plate
• 06438408000058: X-plate, 7 holes
• 06438408000041: C-plate, 7 holes
• 06438408000034: 20 hole plate
• 06438408000027: 4 hole plate