Duns Number:649185170
Device Description: Navigated Pedicle Probe for use with the CarboClear Pedicle Screw System, designed for use Navigated Pedicle Probe for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
Catalog Number
PPS922120N
Brand Name
CarboClear Pedicle Screw System
Version/Model Number
Navigated Probe - Blunt, Straight
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
-
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
K201251
Product Code
NKB
Product Code Name
Thoracolumbosacral Pedicle Screw System
Public Device Record Key
ec8aad61-ab66-4e0e-8325-f1079691eb20
Public Version Date
August 17, 2020
Public Version Number
1
DI Record Publish Date
August 09, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1387 |