Duns Number:041956211
Device Description: CREW, CANN TTAB, 6.5MM X 40MM
Catalog Number
10-SCT-6540
Brand Name
Cosmolock Pedicle Screw System
Version/Model Number
10-SCT-6540
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
NKB
Product Code Name
Thoracolumbosacral Pedicle Screw System
Public Device Record Key
096b8cbb-1a0e-4a0a-aa76-1bf2bb45849b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 15, 2017
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 | 1286 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1900 |