Catalog Number

-

Brand Name

Velofix™ SA Cervical Cage

Version/Model Number

TS4019FT

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

K172424

Product Code

OVE

Product Code Name

Intervertebral fusion device with integrated fixation, cervical

Public Device Record Key

c6d0a3fc-3ba9-474f-abf4-af50e672d47f

Public Version Date

February 24, 2020

Public Version Number

2

DI Record Publish Date

June 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-