Catalog Number

SM-4L

Brand Name

Simplify® Cervical Artificial Disc

Version/Model Number

A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

P200022

Product Code

MJO

Product Code Name

Prosthesis, Intervertebral Disc

Public Device Record Key

8cd55b78-318e-453a-910f-5a17445f2a78

Public Version Date

January 07, 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

-