Inion OTPS™ Biodegradable Screw FRF-1262

GUDID 06438408006388

2.8 x 23 mm screw (2 x)

Inion Oy

Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw

• Primary Device ID: 06438408006388
• NIH Device Record Key: 65b9af49-1f8b-47f0-8324-4f2de487652e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion OTPS™ Biodegradable Screw
• Version Model Number: 1
• Catalog Number: FRF-1262
• 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	06438408006388 [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