CarboClear Posterior Cervical Screw System

Basic Information

• Brand Name: CarboClear Posterior Cervical Screw System
• Primary DI: 07290117351215
• Version / Model: Saw
• Catalog Number: CS031
• Company Name: CARBOFIX ORTHOPEDICS LTD
• Labeler DUNS: 649185170
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-05
• Public Version: 2
• Public Version Date: 2024-11-29
• Public Version Status: Update
• Public Device Record Key: cc6cc639-9cec-4e30-a8ee-7f3598e1a6e4
• Distribution End Date: 2024-11-28

Device Description

Saw for use with the CarboClear Posterior Cervical Screw System rods

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
NKG	Posterior Cervical Screw System	Orthopedic	888.3075	2
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44805	Orthopaedic implantable-device cutter	A heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290117351215	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K233989	000