Inion OTPS™ Biodegradable Screw FRF-1268

GUDID 06438408006418

3.1 x 14 mm screw

Inion Oy

Bioabsorbable orthopaedic bone screw

• Primary Device ID: 06438408006418
• NIH Device Record Key: da7f5d3a-30b6-4d52-b53d-bcf02814f409
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion OTPS™ Biodegradable Screw
• Version Model Number: 1
• Catalog Number: FRF-1268
• 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	06438408006418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043142

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: 2023-10-09
• Device Publish Date: 2023-09-29

On-Brand Devices [Inion OTPS™ Biodegradable Screw]

• M224FRF13059: 3.1 x 30 mm screw
• M224FRF13049: 2.8 x 30 mm screw
• M224FRF12899: 2.0 x 20 mm screw (2 x)
• M224FRF12889: 2.0 x 17 mm screw (2 x)
• M224FRF12879: 2.0 x 15 mm screw (2 x)
• M224FRF12869: 2.0 x 13 mm screw (2 x)
• M224FRF12859: 2.0 x 11 mm screw (2 x)
• M224FRF12849: 2.0 x 9 mm screw (2 x)
• M224FRF12789: 4.5 x 55 mm screw
• M224FRF12779: 4.5 x 50 mm screw
• M224FRF12759: 4.5 x 90 mm cortex screw
• M224FRF12749: 4.5 x 55 mm lag screw
• M224FRF12739: 4.5 x 50 mm lag screw
• M224FRF12729: 4.5 x 45 mm lag screw
• M224FRF12719: 3.1 x 40 mm screw
• M224FRF12709: 3.1 x 18 mm screw
• M224FRF12699: 3.1 x 16 mm screw
• M224FRF12689: 3.1 x 14 mm screw
• M224FRF12679: 3.1 x 12 mm screw
• M224FRF12669: 3.1 x 10 mm screw
• M224FRF12659: 3.1 x 8 mm screw
• M224FRF12649: 3.1 x 6 mm screw
• M224FRF12629: 2.8 x 23 mm screw (2 x)
• M224FRF12619: 2.8 x 18 mm screw (2 x)
• M224FRF12609: 2.8 x 16 mm screw (2 x)
• M224FRF12599: 2.8 x 14 mm screw (2 x)
• M224FRF12589: 2.8 x 12 mm screw (2 x)
• M224FRF12579: 2.8 x 10 mm screw (2 x)
• M224FRF12569: 2.8 x 8 mm screw (2 x)
• M224FRF12559: 2.8 x 6 mm screw (2 x)
• M224FRF12539: 2.5 x 23 mm screw (2 x)
• M224FRF12529: 2.5 x 18 mm screw (2 x)
• M224FRF12519: 2.5 x 16 mm screw (2 x)
• M224FRF12509: 2.5 x 14 mm screw (2 x)
• M224FRF12499: 2.5 x 12 mm screw (2 x)
• M224FRF12489: 2.5 x 10 mm screw (2 x)
• M224FRF12459: 4.5 x 45 mm screw
• M224FRF12449: 4.5 x 40 mm screw
• M224FRF12389: 4.5 x 35 mm screw
• M224FRF12379: 4.5 x 30 mm screw
• M224FRF12369: 4.5 x 25 mm screw
• M224FRF12359: 4.5 x 20 mm screw
• M224FRF12349: 2.5 x 30 mm screw
• M224FRF12259: 2.0 x 7 mm screw (5 + EMGY)
• M224FRF12249: 2.0 x 5 mm screw (5 + EMGY)
• M224FRF12179: 2.8 x 40 mm screw
• M224FRF12079: 2.5 x 8 mm screw (5 x)
• M224FRF12069: 2.5 x 12 mm screw (5 x)
• 06438408010644: 3.1 x 8 mm screw
• 06438408010637: 3.1 x 6 mm screw