CarboClear Vertebral Body Replacement System

Basic Information

• Brand Name: CarboClear Vertebral Body Replacement System
• Primary DI: 07290110206147
• Version / Model: VBR Insertion Handle
• Catalog Number: VBRH10270
• Company Name: CARBOFIX ORTHOPEDICS LTD
• Labeler DUNS: 649185170
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-31
• Public Version: 1
• Public Version Date: 2020-06-08
• Public Version Status: New
• Public Device Record Key: 7acafc02-0879-426a-a626-7a583c798938

Device Description

Handle for use with the CarboClear VBR (vertebral body replacement) 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
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64237	Orthopaedic implant inserter/extractor, single-use	A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290110206147	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192214	000