Inion FreedomScrew™ OSA-4545

GUDID 06438408003332

Screw 4.5 x 45 mm

Inion Oy

Bioabsorbable orthopaedic bone screw

• Primary Device ID: 06438408003332
• NIH Device Record Key: 5dbb9418-463a-4c20-9cbc-1238f2b30b17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inion FreedomScrew™
• Version Model Number: 1
• Catalog Number: OSA-4545
• Company DUNS: 367994657
• Company Name: Inion Oy
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	06438408003332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123672

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 FreedomScrew™]

• M224OSD45559: Screw 4.5 x 55 mm (LAG), cannul.
• M224OSD45509: Screw 4.5 x 50 mm (LAG), cannul.
• M224OSD45459: Screw 4.5 x 45 mm (LAG), cannul.
• M224OSD45409: Screw 4.5 x 40 mm (LAG), cannul.
• M224OSD45359: Screw 4.5 x 35 mm (LAG), cannul.
• M224OSD35459: Screw 3.5 x 45 mm (LAG), cannul.
• M224OSD35409: Screw 3.5 x 40 mm (LAG), cannul.
• M224OSD35359: Screw 3.5 x 35 mm (LAG), cannul.
• M224OSD35309: Screw 3.5 x 30 mm (LAG), cannul.
• M224OSD35259: Screw 3.5 x 25 mm (LAG), cannul.
• M224OSD35209: Screw 3.5 x 20 mm (LAG), cannul.
• M224OSC45909: Screw 4.5 x 90 mm, cannul.
• M224OSC45559: Screw 4.5 x 55 mm, cannul.
• M224OSC45509: Screw 4.5 x 50 mm, cannul.
• M224OSC45459: Screw 4.5 x 45 mm, cannul.
• M224OSC45409: Screw 4.5 x 40 mm, cannul.
• M224OSC45359: Screw 4.5 x 35 mm, cannul.
• M224OSC40909: Screw 4.0 x 90 mm, cannul.
• M224OSC35459: Screw 3.5 x 45 mm, cannul.
• M224OSC35409: Screw 3.5 x 40 mm, cannul.
• M224OSC35359: Screw 3.5 x 35 mm, cannul.
• M224OSC35309: Screw 3.5 x 30 mm, cannul.
• M224OSC35259: Screw 3.5 x 25 mm, cannul.
• M224OSC35209: Screw 3.5 x 20 mm, cannul.
• M224OSB45559: Screw 4.5 x 55 mm (LAG)
• M224OSB45509: Screw 4.5 x 50 mm (LAG)
• M224OSB45459: Screw 4.5 x 45 mm (LAG)
• M224OSB45409: Screw 4.5 x 40 mm (LAG)
• M224OSB45359: Screw 4.5 x 35 mm (LAG)
• M224OSB35459: Screw 3.5 x 45 mm (LAG)
• M224OSB35409: Screw 3.5 x 40 mm (LAG)
• M224OSB35359: Screw 3.5 x 35 mm (LAG)
• M224OSB35309P: Screw 3.5 x 30 mm (LAG)
• M224OSB35259: Screw 3.5 x 25 mm (LAG)
• M224OSB35209: Screw 3.5 x 20 mm (LAG)
• M224OSA45909: Screw 4.5 x 90 mm
• M224OSA45559: Screw 4.5 x 55 mm
• M224OSA45509: Screw 4.5 x 50 mm
• M224OSA45459: Screw 4.5 x 45 mm
• M224OSA45409: Screw 4.5 x 40 mm
• M224OSA45359: Screw 4.5 x 35 mm
• M224OSA35459: Screw 3.5 x 45 mm
• M224OSA35409: Screw 3.5 x 40 mm
• M224OSA35359: Screw 3.5 x 35 mm
• M224OSA35309: Screw 3.5 x 30 mm
• M224OSA35259: Screw 3.5 x 25 mm
• M224OSA35209: Screw 3.5 x 20 mm
• M224OSA27409: Screw 2.7 x 40 mm
• M224OSA27359: Screw 2.7 x 35 mm
• M224OSA27309: Screw 2.7 x 30 mm