ResCUBE™

Basic Information

• Brand Name: ResCUBE™
• Primary DI: 03760185576109
• Version / Model: RCBCUBETUU
• Company Name: COUSIN BIOTECH
• Labeler DUNS: 776742439
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-05
• Public Version: 1
• Public Version Date: 2024-01-15
• Public Version Status: New
• Public Device Record Key: 22e54d1e-203d-48b3-af08-7fceca691f2f

Device Description

The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. It consists of: - A ligament allowing correction and stabilization of the levels, after tensioning - A malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath. The lamella and shrink sleeve are not intended for long term implantation and must be removed after placement of the implant. - A low-profile connector holding the tension on the ligament

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: 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
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	888.3010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44797	Internal spinal fixation system cable	An implantable fixation device designed to apply a force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically made of braided medical grade titanium (Ti) and stainless steel alloy of various lengths and designs (e.g., it may be supplied with or without attached fasteners). The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760185576109	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181799	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.