Coronet

Basic Information

• Brand Name: Coronet
• Primary DI: 00861445000334
• Version / Model: FA01025
• Catalog Number: FA01025
• Company Name: CONEXTIONS MEDICAL INC
• Labeler DUNS: 063692935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-30
• Public Version: 1
• Public Version Date: 2020-07-08
• Public Version Status: New
• Public Device Record Key: e1dd5b2d-28de-4795-8538-877b9428bbc3

Device Description

The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissue washer interconnected via a continuous loop of suture. The implant comes pre-assembled to an inserter, which facilitates concurrent placement of the anchor and soft tissue washer. A drill bit is provided to allow for the creation of a properly sized pilot hole in the bone implantation site.

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 Conditional
• 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
HTN	Washer, Bolt Nut	Orthopedic	888.3030	2
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2
JDR	Staple, Fixation, Bone	Orthopedic	888.3030	2
KGS	Retention Device, Suture	General, Plastic Surgery	878.4930	1
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
45062	Tendon/ligament bone anchor, non-bioabsorbable	A non-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 cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10861445000331	GS1	10-Pack	10	In Commercial Distribution
Primary	00861445000334	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K200028	000