1.5 mm Inion CPS® Baby PLT-1004

GUDID 06438408000065

2 hole plate

Inion Oy

Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable

• Primary Device ID: 06438408000065
• NIH Device Record Key: e698d964-7c6e-4bfe-9b34-275859d67d8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5 mm Inion CPS® Baby
• Version Model Number: 1
• Catalog Number: PLT-1004
• 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	06438408000065 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-27

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