Catalog Number

-

Brand Name

HAWKEYE Vertebral Body Replacement (VBR)

Version/Model Number

WT10-14160030

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K171686

Product Code

MQP

Product Code Name

Spinal vertebral body replacement device

Public Device Record Key

8975cb99-8d2c-4c79-ae49-4468711b9020

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

January 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-