CarboClear Pedicle Screw System

Basic Information

• Brand Name: CarboClear Pedicle Screw System
• Primary DI: 07290109335834
• Version / Model: Locking Element
• Catalog Number: PPLCUR4000
• Company Name: CARBOFIX ORTHOPEDICS LTD
• Labeler DUNS: 649185170
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2018-07-24
• Public Version: 2
• Public Version Date: 2020-10-19
• Public Version Status: Update
• Public Device Record Key: 81ef2ea6-508d-45c2-b3a7-89d8bf5c8d21

Device Description

Locking Element for use as part of the CarboClear Pedicle Screw System

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
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61324	Bone-screw internal spinal fixation system, sterile	An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290109335831	GS1		2	In Commercial Distribution
Primary	07290109335834	GS1
Unit of Use	27290109335838	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173487	000