Duns Number:041956211
Device Description: SCREW, POLY CANN, 7.5MM X 50MM
Catalog Number
10-SCP-7550
Brand Name
Cosmolock Pedicle Screw System
Version/Model Number
10-SCP-7550
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
MNH
Product Code Name
Orthosis, Spondylolisthesis Spinal Fixation
Public Device Record Key
5c028c55-6fd5-4fb7-b0b0-0bad0e07ed76
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 |