Duns Number:830350380
Device Description: INNER SHAFT 6973080 8MM INSERTER US
Catalog Number
-
Brand Name
PRESTIGE® LP Cervical Disc System
Version/Model Number
6973080
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
2ad505f7-7b8d-46ed-8390-9197a8036094
Public Version Date
April 23, 2019
Public Version Number
6
DI Record Publish Date
September 25, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |