Catalog Number

5901-0369

Brand Name

4CIS® Marlin ACIF Cage SYSTEM

Version/Model Number

5901-0369

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

K162402,K192044

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Public Device Record Key

09b3a6da-0b5b-4a6d-a735-cc022bf73b45

Public Version Date

March 28, 2022

Public Version Number

4

DI Record Publish Date

November 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-