Catalog Number

DG-LG

Brand Name

Simplify® Cervical Artificial Disc

Version/Model Number

F

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

P200022

Product Code

MJO

Product Code Name

Prosthesis, Intervertebral Disc

Public Device Record Key

2593ff57-8446-4ca9-8006-f2b9948027bd

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

December 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-