4CIS VANE SPINE SYSTEM

Basic Information

• Brand Name: 4CIS VANE SPINE SYSTEM
• Primary DI: 08800033382027
• Version / Model: 4242-0004
• Catalog Number: 4242-0004
• Company Name: ALPHA AI CO.,LTD.
• Labeler DUNS: 687844241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 8
• Public Version Date: 2026-01-19
• Public Version Status: Update
• Public Device Record Key: 49f23535-a9f7-41c2-8382-1d8db2d28eac

Device Description

Nut Screw, VANE 5.7 Type, Yellow

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: 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
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	888.3070	2
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65553	Spinal bone set screw	A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800033382027	GS1

Premarket Submissions

Submission Number	Supplement Number
K101818	000