Duns Number:536935331
Device Description: The QWIX stabilization screw is a cannulated titanium alloy screw with a long non-threaded The QWIX stabilization screw is a cannulated titanium alloy screw with a long non-threaded shaft, allowing optimal compression and has a self-tapping screw tip. These features enable its use in bone fixation. Its length can vary from 22 to 60mm for the 4.3mm diameter QWIX stabilization screw. The screw is cannulated in order to enable the use of a K-wire for optimal positioning. Delivered non sterile.
Catalog Number
111460ND
Brand Name
QWIX
Version/Model Number
111460ND
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
K050346
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
1648a287-693f-43de-95d0-f1a1d7b63b0a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 09, 2017
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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |