Duns Number:053950783
Device Description: Simplify® Trial, Size LG, Height 5, 5° Lordosis
Catalog Number
T-LG-5L
Brand Name
Simplify® Cervical Artificial Disc
Version/Model Number
E
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
432bfd66-bb05-4a3d-b656-33f9c657b8e4
Public Version Date
February 04, 2022
Public Version Number
3
DI Record Publish Date
December 14, 2020
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 | 4207 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38751 |
| 3 | A medical device with high risk that requires premarket approval | 84 |
| U | Unclassified | 29 |