Duns Number:687844241
Device Description: 4CIS® Chiron Poly Axial Cannulated Screw Ø4.5 X 20mm (Rod Ø5.5)
Catalog Number
4146-4520
Brand Name
4CIS® Chiron Spinal Fixation System
Version/Model Number
4146-4520
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
K190471
Product Code
NKB
Product Code Name
Thoracolumbosacral Pedicle Screw System
Public Device Record Key
2915c6a4-6e4e-491b-836b-302a2eb572cf
Public Version Date
November 19, 2019
Public Version Number
1
DI Record Publish Date
November 11, 2019
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 | 969 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6429 |