510(k) K093914 ยท HRS Plate, Fixation, Bone
NEWDEAL COMPRESSION PLATES
| Applicant | Newdeal Sas, Planisboro NJ, US |
| Decision | Substantially Equivalent, Apr 14, 2011 |
| Received | Dec 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093914
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2018 | NewDeal SA UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, &
330430S Terminated |
HRS | None listed |
| Jul 16, 2018 | NewDeal SA ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S,
181001S, 181002S, 181003S & 181004S Terminated |
HRS | None listed |
| Jul 16, 2018 | NewDeal SA ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S Terminated |
HRS | None listed |
| Jul 16, 2018 | NewDeal SA Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S,
111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S,
111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S,
121745S, 1 Terminated |
HRS | None listed |
| Jul 16, 2018 | NewDeal SA TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S,
150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S,
150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S,
150285S, 1 Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.