Duns Number:927083808
Device Description: BOTTOM LEVEL, JANUS FENESTRATED IMPLANT & INSTRUMENT CASE
Catalog Number
-
Brand Name
FENESTRATED SCREWS
Version/Model Number
36-6320
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"
Yes
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
K180179
Product Code
NKB
Product Code Name
Thoracolumbosacral pedicle screw system
Public Device Record Key
7a3f024f-c278-4352-b02d-9d4b5217f85c
Public Version Date
March 20, 2019
Public Version Number
1
DI Record Publish Date
March 12, 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 | 2497 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5891 |
| 3 | A medical device with high risk that requires premarket approval | 104 |