OSSIOfiber® Suture Anchor

Basic Information

• Brand Name: OSSIOfiber® Suture Anchor
• Primary DI: 07290017630946
• Version / Model: OF1035551S
• Catalog Number: OF1035551S
• Company Name: OSSIO LTD
• Labeler DUNS: 600505107
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-14
• Public Version: 1
• Public Version Date: 2023-09-22
• Public Version Status: New
• Public Device Record Key: 21494ecd-478c-46fd-a5c9-df40b38bba5d

Device Description

OSSIOfiber® Suture Anchor 5.5 mm with Suture Snare. Package contains: 1 Implant,1 Inserter,1 Suture Snare.

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: Labeling does not contain MRI Safety Information
• 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
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45061	Tendon/ligament bone anchor, bioabsorbable	A bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017630946	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K213415	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	5.5	Millimeter

Storage Conditions

• 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
• Type: Storage Environment Temperature
• Temperature Range: 7 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry