CarboClear X Pedicle Screw System

Basic Information

• Brand Name: CarboClear X Pedicle Screw System
• Primary DI: 07290117355077
• Version / Model: Pedicle Screw - Dual Thread
• Catalog Number: XDT5025
• Company Name: CARBOFIX ORTHOPEDICS LTD
• Labeler DUNS: 649185170
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-03
• Public Version: 1
• Public Version Date: 2025-04-11
• Public Version Status: New
• Public Device Record Key: 06c77ce4-e9a6-4adb-9208-8715f8856826

Device Description

CarboClear X Dual Thread Pedicle Screw Solid

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
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	888.3027	2
OLO	Orthopedic Stereotaxic Instrument	Neurology	882.4560	2
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46651	Spinal bone screw, non-bioabsorbable	A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290117355074	GS1		2	In Commercial Distribution
Primary	07290117355077	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K231280	000
K233793	000
K240846	000

Device Sizes

Type	Value	Unit	Text
Length	25	Millimeter
Outer Diameter	5.0	Millimeter