Panels › General, Plastic Surgery › Product code HTE · Class 1
Elevator
Regulation 878.4800
0510(k)s in 12 months (0 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in HTE
| Company | 510(k)s | Recalls |
|---|---|---|
| SpineFrontier, Inc. | 0 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2014 | SpineFrontier, Inc. Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14
The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stain Terminated |
HTE | None listed |
| Jan 16, 2014 | SpineFrontier, Inc. Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16
The trial heads are smooth plates that mimic the footprint of the implant, manufactured f Terminated |
HTE | None listed |
| Jan 16, 2014 | SpineFrontier, Inc. Arena-L Trial Handle; Part: 11-81002
The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012 Terminated |
HTE | None listed |
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