Duns Number:079840876
Device Description: CORTICAL SHANK, Cannulated, 9.5 X 95
Catalog Number
MC1-195095
Brand Name
Mariner Cortical
Version/Model Number
MC1-195095
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 21, 2021
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
K173882
Product Code
NKB
Product Code Name
Thoracolumbosacral pedicle screw system
Public Device Record Key
57839ce6-416a-4581-91a3-fe0cbfce73b6
Public Version Date
July 21, 2021
Public Version Number
2
DI Record Publish Date
January 09, 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 | 5602 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14020 |
| U | Unclassified | 21 |