OSSIOfiber® Compression Screw OF1073538S

GUDID 07290017630847

OSSIOfiber® Compression Screw, 3.5X38 mm. Package contains: 1 Implant.

OSSIO LTD

Bioabsorbable orthopaedic bone screw

• Primary Device ID: 07290017630847
• NIH Device Record Key: 4764389b-1871-442d-97ce-b7108066225c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSIOfiber® Compression Screw
• Version Model Number: OF1073538S
• Catalog Number: OF1073538S
• Company DUNS: 600505107
• Company Name: OSSIO LTD
• Device Count: 1
• DM Exempt: false
• 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

Customer Support Contacts

• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 38 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 7 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store at a normal relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
• Storage Environment Temperature: Between 7 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store at a normal relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
• Storage Environment Temperature: Between 7 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store at a normal relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
• Storage Environment Temperature: Between 7 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store at a normal relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
• Storage Environment Temperature: Between 7 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store at a normal relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F
• Storage Environment Temperature: Between 7 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store at a normal relative humidity
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017630847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231272

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: 2025-10-06
• Device Publish Date: 2025-09-26

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