OSSIOfiber® Hammertoe Fixation System

Basic Information

• Brand Name: OSSIOfiber® Hammertoe Fixation System
• Primary DI: 07290017630106
• Version / Model: OF20029191
• Catalog Number: OF20029191
• Company Name: OSSIO LTD
• Labeler DUNS: 600505107
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-12
• Public Version: 2
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 37635d2e-1494-4a6b-8601-ef7ec1f14f0f

Device Description

The OSSIOfiber® Hammertoe Fixation System, M, 2.9X19 mm, angled 10°. Package contains: 1 K-wire, 1 Drill Bit, 1 Inserter, 1 Implant angled 10°.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTY	Pin, Fixation, Smooth	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45037	Orthopaedic bone pin, bioabsorbable	A device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017630106	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K190652	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	2.9	Millimeter
Length	19	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not expose product to temperatures greater than 47°C or 116°F.
• Type: Special Storage Condition, Specify
• Special Conditions: Store at a normal relative humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Temperature
• Temperature Range: 7 – 30 Degrees Celsius