2.0 mm Inion OTPS™ FRF-1016

GUDID 06438408005855

10 hole plate

Inion Oy

Orthopaedic fixation plate, bioabsorbable

• Primary Device ID: 06438408005855
• NIH Device Record Key: 10ba516c-562a-4744-b068-f7074d42e8bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.0 mm Inion OTPS™
• Version Model Number: 1
• Catalog Number: FRF-1016
• Company DUNS: 367994657
• Company Name: Inion Oy
• Device Count: 1
• DM Exempt: false
• 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	06438408005855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023887

FDA Product Code

• HRS: Plate, 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: 2023-10-09
• Device Publish Date: 2023-09-29

On-Brand Devices [2.0 mm Inion OTPS™]

• M224FRF10409: L-plate left, 7 holes
• M224FRF10399: L-plate right, 7 holes
• M224FRF10389: 6 hole plate
• M224FRF10379: X-plate, 7 holes
• M224FRF10229: 2 hole plate
• M224FRF10169: 10 hole plate
• M224FRF10149: 4 hole plate, extended
• M224FRF10139: 4 hole plate
• M224PIN50029: 2.0 mm Pins
• M224PIN20509: 2.0 x 50 mm pin
• M224PIN20409: 2.0 x 40 mm pin
• M224PIN20359: 2.0 x 35 mm pin
• M224PIN20309: 2.0 x 30 mm pin
• M224PIN20259: 2.0 x 25 mm pin
• M224PIN20209: 2.0 x 20 mm pin
• M224PCK70029: 2.0 mm Pin Kit
• 06438408010323: 2 hole plate
• 06438408006104: 2.0 mm Pins
• 06438408006081: 2.0 x 50 mm pin
• 06438408006074: 2.0 x 40 mm pin
• 06438408006067: 2.0 x 35 mm pin
• 06438408006050: 2.0 x 30 mm pin
• 06438408006043: 2.0 x 25 mm pin
• 06438408005985: 2.0 mm Pin Kit
• 06438408005954: L-plate left, 7 holes
• 06438408005947: L-plate right, 7 holes
• 06438408005930: 6 hole plate
• 06438408005923: X-plate, 7 holes
• 06438408005855: 10 hole plate
• 06438408005848: 4 hole plate, extended
• 06438408005831: 4 hole plate
• 06438408006036: 2.0 x 20 mm pin
• 06438408012419: 2.0 mm Pins
• 06438408012402: 2.0 mm Pin Kit