EVOL®SI Joint Fusion System

Basic Information

• Brand Name: EVOL®SI Joint Fusion System
• Primary DI: 00841193124995
• Version / Model: CES-318
• Company Name: Cutting Edge Spine, LLC
• Labeler DUNS: 069472647
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-26
• Public Version: 1
• Public Version Date: 2024-05-06
• Public Version Status: New
• Public Device Record Key: 8af9dd9d-b8d2-4e80-a986-3ba6f5b95520

Device Description

EVOL®SI Stackable Steinmann Pin, 3.2 Blunt End

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUR	Sacroiliac Joint Fixation	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58927	Orthopaedic prosthesis implantation positioning instrument, single-use	A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841193124995	GS1

Customer Contacts

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