Duns Number:649185170
Device Description: Fenestrated pedicle screw (oncology)
Catalog Number
PNNSC6535FN
Brand Name
CarboClear X Pedicle Screw System
Version/Model Number
Pedicle Screw - Fenestrated
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
K190526,K210716,K190526,K210716
Product Code
NKB
Product Code Name
Thoracolumbosacral Pedicle Screw System
Public Device Record Key
1c7ed766-0ca0-49ee-a0ea-a088b2432931
Public Version Date
January 24, 2022
Public Version Number
1
DI Record Publish Date
January 16, 2022
Package DI Number
17290117350277
Quantity per Package
2
Contains DI Package
07290117350270
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1387 |