Catalog Number

-

Brand Name

PRESTIGE® LP Cervical Disc System

Version/Model Number

6972448

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

P090029

Product Code

MJO

Product Code Name

PROSTHESIS, INTERVERTEBRAL DISC

Public Device Record Key

29f5dae1-ceca-4b0f-9cda-64c9977a66dc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 25, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-