GENIE PEEK/Bio Knotless Anchor

Basic Information

• Brand Name: GENIE PEEK/Bio Knotless Anchor
• Primary DI: 08800298539143
• Version / Model: 375BCP
• Company Name: OSTEONIC CO.,Ltd.
• Labeler DUNS: 688999370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-06
• Public Version: 2
• Public Version Date: 2025-03-18
• Public Version Status: Update
• Public Device Record Key: c8b0e04c-9db1-474e-8232-2dcce76dfa78

Device Description

3.75mm Bio PEEK anchor

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: No
• 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
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	888.3040	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	08800298539143	GS1

Premarket Submissions

Submission Number	Supplement Number
K243467	000