Duns Number:536935331
Device Description: The QWIX positioning and fixation screw are designed to provide speed and precision for ch The QWIX positioning and fixation screw are designed to provide speed and precision for challenging surgical situations. They are indicated for fixation of bone fractures or for bone reconstructions. QWIX 3.0 and 4.3 are designed with self-drilling flutes. The compression screw has a non-threaded shaft and a self-tapping screw tip. Instruments are also provided.
Catalog Number
QWX34INSTSET
Brand Name
QWIX
Version/Model Number
QWX34INSTSET
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
-
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
K022599,K050346
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
8f373c35-367f-4d49-a0f0-384a31989634
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |