M-Fix 7mm

Basic Information

• Brand Name: M-Fix 7mm
• Primary DI: 00860366001420
• Version / Model: FG3007
• Company Name: CORACOID SOLUTIONS LLC
• Labeler DUNS: 073670228
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-18
• Public Version: 1
• Public Version Date: 2018-07-19
• Public Version Status: New
• Public Device Record Key: d1e54f43-11a4-4e38-b4bf-2349fb70fd6e

Device Description

Surgical implant to reduce and stabilize the acromioclavicular joint.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
HTN	Washer, Bolt Nut	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62000	Acromioclavicular joint stabilization implant	A sterile implantable device intended to be used to approximate/stabilize the acromioclavicular joint to facilitate healing of a disrupted coracoclavicular ligament (i.e., the device is not intended to replace the damaged ligament). It is in the form of a cord with a loop for attachment to the coracoid process at one end, with a component for fixation to the clavicle (e.g., screw) at the other end. It may be implanted arthroscopically or during open surgery.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860366001420	GS1

Premarket Submissions

Submission Number	Supplement Number
K153211	000