Skip to content

Qwix 111312ND

by Newdeal Sas

Qwix 111312ND 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 10381780046516), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

510(k) K050346

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780046516 UDI-DI Date9 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050346 Date17 Mar 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050346 decided 17 Mar 2005 Active
  • FDA GUDID UDI-DI 10381780046516 listed 9 Oct 2017 Listed

Recalls

4 recalls · FDA

    • Terminated Z-1253-2010 FDA Unclassified (pre-2012) initiated 8 Feb 2010

    The screws were etched incorrectly as 34mm instead of the correct 32mm.

    • Terminated Z-1254-2010 FDA Unclassified (pre-2012) initiated 8 Feb 2010

    The screws were etched incorrectly as 32mm instead of the correct 34mm length.

    • Terminated Z-1445-2008 FDA Unclassified (pre-2012) initiated 27 Feb 2008

    Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length.

    • Terminated Z-1446-2008 FDA Unclassified (pre-2012) initiated 27 Feb 2008

    Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length.

Timeline

6 dated events

  1. Cleared FDA 510(k) K050346
  2. Recall initiated FDA recalls Z-1445-2008
  3. Recall initiated FDA recalls Z-1446-2008
  4. Recall initiated FDA recalls Z-1253-2010
  5. Recall initiated FDA recalls Z-1254-2010
  6. Listed FDA GUDID 10381780046516

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Qwix
Generic name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / Ref / Catalog
111312ND
Primary DI / UDI-DI
10381780046516
510(k) Number
FDA product code
HWC
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile

Cleared under the same submission (K050346)

and 8 more cleared under K050346

Similar devices in this category

Other devices filed under Orthopaedic bone screw, non-bioabsorbable, non-sterile.

Other devices from Newdeal Sas

See all devices from Newdeal Sas →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)