Catalog Number

MPU8-C12B

Brand Name

4CIS® Marlin ACIF Cage SYSTEM

Version/Model Number

MPU8-C12B

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

K192044

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Public Device Record Key

0ee994df-276b-496d-b73b-1c01077a6c28

Public Version Date

May 04, 2020

Public Version Number

1

DI Record Publish Date

April 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-