Large QWIX 111560SND
by Newdeal Sas
Large QWIX 111560SND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K050346 on 17 Mar 2005 and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780047094), active as of 23 Oct 2026. 4 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10381780047094 | Date9 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050346 | Date17 Mar 2005 | StatusActive |
Official records
- AccessGUDID record 10381780047094
- FDA 510(k) database K050346
Across registries
- FDA 510(k) K050346 decided 17 Mar 2005 Active
- FDA GUDID UDI-DI 10381780047094 listed 9 Oct 2017 Listed
Recalls
-
- Terminated Z-1253-2010
The screws were etched incorrectly as 34mm instead of the correct 32mm.
-
- Terminated Z-1254-2010
The screws were etched incorrectly as 32mm instead of the correct 34mm length.
-
- Terminated Z-1445-2008
Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length.
-
- Terminated Z-1446-2008
Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length.
Timeline
- Cleared FDA 510(k) K050346
- Recall initiated FDA recalls Z-1445-2008
- Recall initiated FDA recalls Z-1446-2008
- Recall initiated FDA recalls Z-1253-2010
- Recall initiated FDA recalls Z-1254-2010
- Listed FDA GUDID 10381780047094
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Large QWIX
- Generic name
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Model / Ref / Catalog
- 111560SND
- Primary DI / UDI-DI
- 10381780047094
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
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