NewDeal SA
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2446-2018 | Class II | Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, | May 22, 2018 |
| Z-2443-2018 | Class II | UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225 | May 22, 2018 |
| Z-2447-2018 | Class II | TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 1 | May 22, 2018 |
| Z-2445-2018 | Class II | ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 1810 | May 22, 2018 |
| Z-2444-2018 | Class II | ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004 | May 22, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K103623 | NEWDEAL INTERPHALANGEAL IMPLANT | March 20, 2012 |
| K093914 | NEWDEAL COMPRESSION PLATES | April 14, 2011 |
| K093781 | MODIFIED: NEWDEAL HALLU PLATES | January 22, 2010 |
| K091788 | PANTA NAIL (DIA. 10MM), PANTA NAIL XL | July 29, 2009 |
| K083154 | NEWDEAL HALLU LOCK PLATE SYSTEM | July 10, 2009 |
| K091609 | NEWDEAL COMPRESSION PLATE | June 30, 2009 |
| K073375 | NEWDEAL TIBIAXYS SYSTEM | February 21, 2008 |
| K071639 | QWIX POSITIONING SCREW | July 9, 2007 |
| K070447 | NEWDEAL COMPRESSION PLATE | March 29, 2007 |
| K063831 | BASAL DORSAL PLATES | February 7, 2007 |