Duns Number:081224143
Device Description: Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 30
Catalog Number
-
Brand Name
Fortex Pedicle Screw System
Version/Model Number
X022-5530SD-DL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K090224
Product Code
MNH
Product Code Name
Orthosis, spondylolisthesis spinal fixation
Public Device Record Key
d1f3c16e-0395-4bf8-afe2-d14d60f9a0c9
Public Version Date
June 03, 2021
Public Version Number
5
DI Record Publish Date
October 19, 2015
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 | 1719 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3162 |
| U | Unclassified | 25 |