CarboClear Posterior Cervical Screw System

Basic Information

• Brand Name: CarboClear Posterior Cervical Screw System
• Primary DI: 07290117353516
• Version / Model: Curved Rod
• Catalog Number: CRC4080
• Company Name: CARBOFIX ORTHOPEDICS LTD
• Labeler DUNS: 649185170
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-06-05
• Public Version: 1
• Public Version Date: 2024-06-13
• Public Version Status: New
• Public Device Record Key: 06bc1177-7acb-4764-b330-327a658ab7fa

Device Description

Posterior cervical rod

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

GMDN Terms

Code	Name	Definition	Implantable	Status
65116	Bone-screw internal spinal fixation system rod	An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290117353513	GS1		2	In Commercial Distribution
Primary	07290117353516	GS1
Unit of Use	27290117353510	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K233989	000

Device Sizes

Type	Value	Unit	Text
Length	80	Millimeter
Outer Diameter	4.0	Millimeter