Duns Number:183641617
Device Description: PLATEAU-C 20mm x 16mm x 9mm Interbody, Biconvex, 0°
Catalog Number
36-2016-109
Brand Name
Plateau-C Spacer System
Version/Model Number
36-2016-109
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
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
K111835
Product Code
ODP
Product Code Name
Intervertebral fusion device with bone graft, cervical
Public Device Record Key
0f7755c4-78f9-433d-8c9e-90345e522c3f
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
November 14, 2019
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 | 315 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9180 |
| U | Unclassified | 47 |