CarboClear Vertebral Body Replacement System - A spinal vertebral body replacement device - CARBOFIX ORTHOPEDICS LTD

Duns Number:649185170

Device Description: A spinal vertebral body replacement device

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More Product Details

Catalog Number

VBR3527575

Brand Name

CarboClear Vertebral Body Replacement System

Version/Model Number

VBR Spacer

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192214

Product Code Details

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Device Record Status

Public Device Record Key

7df0e28d-9436-4cbb-a657-d294b754c1a6

Public Version Date

October 19, 2020

Public Version Number

3

DI Record Publish Date

November 07, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARBOFIX ORTHOPEDICS LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1387