Duns Number:649185170
Device Description: Cannulated pedicle screw
Catalog Number
PNNSC7550N
Brand Name
CarboClear X Pedicle Screw System
Version/Model Number
Pedicle Screw - Cannulated
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
K210716,K210716
Product Code
NKB
Product Code Name
Thoracolumbosacral Pedicle Screw System
Public Device Record Key
89d65860-e086-4164-8e46-acf190d92175
Public Version Date
February 23, 2022
Public Version Number
1
DI Record Publish Date
February 15, 2022
Package DI Number
17290117350567
Quantity per Package
2
Contains DI Package
07290117350560
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 |