OSSIOfiber™ Hammertoe Fixation Implant OF10129190

GUDID 07290017630007

The OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

OSSIO LTD

Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable Orthopaedic bone pin, bioabsorbable

• Primary Device ID: 07290017630007
• NIH Device Record Key: 78d7e0f8-765f-42dc-be01-d21b0d98c6b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSIOfiber™ Hammertoe Fixation Implant
• Version Model Number: 2.9X19 mm straight
• Catalog Number: OF10129190
• 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: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io
• Phone: 1-833-781-7373
• Email: info@ossio.io

Device Dimensions

• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 2.9 Millimeter

Operating and Storage Conditions

• 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.
• 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.
• 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	07290017630007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181180

FDA Product Code

• HTY: Pin, Fixation, Smooth

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: 2019-04-23
• Device Publish Date: 2019-04-15

Devices Manufactured by OSSIO LTD

• 07290019361022 - OSSIOfiber® Trimmable Fixation Nail System, Cannulated: 2024-07-08 OSSIOfiber® Trimmable Fixation Nail System, 4.0x100mm, Cannulated. Package contains: 1 Implant, and 1 instrument pack.
• 07290017630670 - OSSIOfiber® Compression Staple System: 2024-05-24 OSSIOfiber® Compression Staple System, 9 x 10 mm. Package contains: 1 Implant, and 1 Instrument pack.
• 07290019361008 - OSSIOfiber® Compression Staple: 2024-05-24 OSSIOfiber® Compression Staple, 9X10 mm. Package contains: 1 Implant.
• 07290019361015 - OSSIOfiber® Compression Staple: 2024-05-24 OSSIOfiber® Compression Staple, 11X10 mm. Package contains: 1 Implant.
• 07290019361039 - OSSIOfiber® Compression Staple System: 2024-05-24 OSSIOfiber® Compression Staple System, 11 x 10 mm Package contains: 1 Implant, and 1 Instrument pack.
• 07290017630700 - OSSIOfiber® Compression Staple System: 2024-05-16 OSSIOfiber® Compression Staple System, 20 x 20 mm. Package contains: 1 Implant, and 1 Instrument pack.
• 07290017630717 - OSSIOfiber® Compression Staple System: 2024-05-16 OSSIOfiber® Compression Staple System, 25 x 22 mm Package contains: 1 Implant, and 1 Instrument pack.
• 07290019361060 - OSSIOfiber® Trimmable Fixation Nail, Cannulated: 2024-02-02 OSSIOfiber® Trimmable Fixation Nail, 4.0x100mm, Cannulated. Package contains: 1 Implant.