Catalog Number

03835401

Brand Name

SYNFIX Evolution

Version/Model Number

03.835.401

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

-

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

K150673,K150673

Product Code

OVD

Product Code Name

Intervertebral fusion device with integrated fixation, lumbar

Public Device Record Key

010d4e2c-fb03-4905-9fa8-d24e6bf338ce

Public Version Date

April 27, 2022

Public Version Number

2

DI Record Publish Date

July 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-