Sternal Cable System

Basic Information

• Brand Name: Sternal Cable System
• Primary DI: 00846468041168
• Version / Model: 408-721
• Company Name: Pioneer Surgical Technology, Inc.
• Labeler DUNS: 793384496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-09
• Public Version: 5
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 1dc7e8b6-8c6b-4696-8dfa-a8da60b81cae

Device Description

Ti Reverse Cutting Needle, 4 Cables Per Pouch

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
JDQ	Cerclage, Fixation	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	00846468041168	GS1

Premarket Submissions

Submission Number	Supplement Number
K935481	000