CoFix Implant 12 mm

Basic Information

• Brand Name: CoFix Implant 12 mm
• Primary DI: 04260148898259
• Version / Model: RQI00012
• Catalog Number: RQI00012
• Company Name: Paradigm Spine GmbH
• Labeler DUNS: 537619731
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-19
• Public Version: 3
• Public Version Date: 2021-06-10
• Public Version Status: Update
• Public Device Record Key: 7e373cf6-5991-4156-ad0c-4742b01cb592

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: 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
PEK	Spinous Process Plate	Orthopedic	888.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61533	Interspinous spinal fixation implant	An implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260148898259	GS1

Premarket Submissions

Submission Number	Supplement Number
K153302	000

Device Sizes

Type	Value	Unit	Text
Height	12	Millimeter