OSSIOfiber® Compression Staple

Basic Information

• Brand Name: OSSIOfiber® Compression Staple
• Primary DI: 07290017630892
• Version / Model: OF1062020S
• Catalog Number: OF1073520S
• Company Name: OSSIO LTD
• Labeler DUNS: 600505107
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-25
• Public Version: 1
• Public Version Date: 2023-01-02
• Public Version Status: New
• Public Device Record Key: a4abf3d6-65db-4c1d-ae5e-18c703c9854f

Device Description

OSSIOfiber® Compression Staple, 20x20 mm. Package contains: 1 Implant.

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
MNU	Staple, Absorbable	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61669	Orthopaedic bone staple, non-adjustable	A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017630892	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K212594	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20 x 20 mm

Storage Conditions

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