VariTrax Sternal CircumFixator Set

Basic Information

• Brand Name: VariTrax Sternal CircumFixator Set
• Primary DI: 00850049938013
• Version / Model: CFSK-0142
• Company Name: CircumFix Solutions, Inc.
• Labeler DUNS: 057130264
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-01
• Public Version: 2
• Public Version Date: 2025-06-25
• Public Version Status: Update
• Public Device Record Key: 1100d808-82f7-43dd-9c9d-940c1b80da2e

Device Description

VariTrax Sternal CircumFixator Set, 142mm

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
JDQ	Cerclage, Fixation	Orthopedic	888.3010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34017	Sternal fixation device	A collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850049938013	GS1

Premarket Submissions

Submission Number	Supplement Number
K232986	000