Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K110367
PIONEER SPINAL PROCESS FUSION PLATE · Pioneer Surgical Technology, Inc. · decided 2011-03-23 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Spinous Process Plate, 14mm | SR08-4614 | Surgentec, LLC | KWP | 00810131880828 |
| Spinous Process Plate, 16mm | SR08-4616 | Surgentec, LLC | KWP | 00810131880835 |
| Spinous Process Plate, 12mm | SR08-4612 | Surgentec, LLC | KWP | 00810131880811 |
| Spinous Process Plate, 10mm | SR08-4610 | Surgentec, LLC | KWP | 00810131880804 |
| Spinous Process Plate, 8mm | SR08-4608 | Surgentec, LLC | KWP | 00810131880798 |