1.5 mm Inion CPS® PLT-1081

GUDID M224PLT10819

Orbital plate 25x24 mm

Inion Oy

Orthopaedic fixation plate, bioabsorbable

• Primary Device ID: M224PLT10819
• NIH Device Record Key: 507f7c66-4db8-46cb-9729-c6810d614ade
• Commercial Distribution Discontinuation: 2026-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5 mm Inion CPS®
• Version Model Number: 1
• Catalog Number: PLT-1081
• 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	M224PLT10819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122890

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: 3
• Public Version Date: 2023-08-28
• Device Publish Date: 2018-03-26

On-Brand Devices [1.5 mm Inion CPS®]

• M224PLT10319: Mesh plate, 14x14 holes
• M224PLT10309: Mesh plate, 7x7 holes
• 06438408011504: 1.5 x 6 mm screw (5 + EMGY)
• 06438408011498: 1.5 x 4 mm screw (5 + EMGY)
• 06438408011368: Mesh plate, 14x14 holes
• 06438408011351: Mesh plate, 7x7 holes
• 06438408011122: Orbital sheet 40x40 mm, anatomic
• 06438408011115: Orbital sheet 30x28 mm, with legs
• 06438408011108: Orbital plate 30x28 mm, with legs
• 06438408011092: Orbital sheet 30x28 mm
• 06438408011085: Orbital plate 30x28 mm
• 06438408011078: Orbital sheet 25x24 mm
• 06438408011061: Orbital plate 25x24 mm
• 06438408011054: X-plate, 7 holes
• 06438408011047: Burrhole plate
• 06438408011030: L-plate left, 7 holes
• 06438408011023: L-plate right, 7 holes
• 06438408011016: C-plate, 7 holes
• 06438408011009: 20 hole plate
• 06438408010996: 6 hole plate
• 06438408010989: 4 hole plate
• M224SCR12239: 1.5 x 6 mm screw (5 + EMGY)
• M224SCR12229: 1.5 x 4 mm screw (5 + EMGY)
• M224PLT10879: Orbital sheet 40x40 mm, anatomic
• M224PLT10869: Orbital sheet 30x28 mm, with legs
• M224PLT10859: Orbital plate 30x28 mm, with legs
• M224PLT10849: Orbital sheet 30x28 mm
• M224PLT10839: Orbital plate 30x28 mm
• M224PLT10829: Orbital sheet 25x24 mm
• M224PLT10819: Orbital plate 25x24 mm
• M224PLT10129: X-plate, 7 holes
• M224PLT10119: Burrhole plate
• M224PLT10109: L-plate left, 7 holes
• M224PLT1009: L-plate right, 7 holes
• M224PLT10089: C-plate, 7 holes
• M224PLT10079: 20 hole plate
• M224PLT10069: 6 hole plate
• M224PLT10059: 4 hole plate
• 06438408000898: 1.5 x 6 mm screw (5 + EMGY)
• 06438408000881: 1.5 x 4 mm screw (5 + EMGY)
• 06438408000751: Mesh plate, 14x14 holes
• 06438408000744: Mesh plate, 7x7 holes
• 06438408000515: Orbital sheet 40x40 mm, anatomic
• 06438408000508: Orbital sheet 30x28 mm, with legs
• 06438408000492: Orbital plate 30x28 mm, with legs
• 06438408000485: Orbital sheet 30x28 mm
• 06438408000478: Orbital plate 30x28 mm
• 06438408000461: Orbital sheet 25x24 mm
• 06438408000454: Orbital plate 25x24 mm
• 06438408000447: X-plate, 7 holes