Duns Number:081363044
Device Description: 6.5mm x 55mm MIS eX-TAB Screw, Cannulated
Catalog Number
-
Brand Name
Fortuna MIS eX-TAB Stabilization System
Version/Model Number
211-65055-1
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
K162576
Product Code
MNH
Product Code Name
Orthosis, Spondylolisthesis Spinal Fixation
Public Device Record Key
4717e605-c041-442d-af82-6779bb9cb958
Public Version Date
September 24, 2020
Public Version Number
1
DI Record Publish Date
September 16, 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. | 75 |