Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K170021
SMV Scientific Cannulated Screws · Smv Scientific · decided 2017-05-22 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Ø8.0 x 70mm x 24mm CANNULATED PARTIAL THREAD | 380-5070-024 | Osteocentric Technologies, Inc. | HWC | 00816950027215 |
| Ø7.0 x 58mm x 110mm CANNULATED PARTIAL THREAD SCREW | 370-5110-058 | Osteocentric Technologies, Inc. | HWC | 00816950027048 |
| Ø7.0 x 24mm x 150mm CANNULATED PARTIAL THREAD SCREW | 370-5150-024 | Osteocentric Technologies, Inc. | HWC | 00816950026898 |
| 4.0 X 26mm CANN SCREW FASTENER Ti FL THD | 320-40026-03 | Osteocentric Technologies, Inc. | HWC | 00810074304689 |
| 4.0 X 52mm CANN SCREW FASTENER Ti SH THD | 320-40052-01 | Osteocentric Technologies, Inc. | HWC | 00810074303194 |
| 2.74mm Guidewire, Threaded Trocar Tip SS, 450mm | 2004-0018 | Osteocentric Technologies, Inc. | FZX | 00816950028649 |
| 2.5mm Hex Driver, AO QC Shaft 290mm | 2016-0002 | Osteocentric Technologies, Inc. | HXX | 00816950028625 |
| 4.0 X 42mm CANN SCREW FASTENER Ti FL THD | 320-40042-03 | Osteocentric Technologies, Inc. | HWC | 00810074304764 |
| Trocar | 2004-0001-05 | Osteocentric Technologies, Inc. | LXH | 00816950027857 |
| Drill Sleeve | 2004-0001-03 | Osteocentric Technologies, Inc. | FZX | 00816950027833 |
| 7.0mm Drill, Cann, Hudson-Mod, 190mm | 2004-0020 | Osteocentric Technologies, Inc. | HTW | 00816950027826 |
| Ø7.0 x 24mm x 130mm CANNULATED PARTIAL THREAD SCREW | 370-5130-024 | Osteocentric Technologies, Inc. | HWC | 00816950026850 |
| 4.0 X 40mm CANN SCREW FASTENER Ti FL THD | 320-40040-03 | Osteocentric Technologies, Inc. | HWC | 00810074304757 |
| Ø7.0 x 24mm x 55mm CANNULATED PARTIAL THREAD SCREW | 370-5055-024 | Osteocentric Technologies, Inc. | HWC | 00816950026706 |
| 4.0 X 22mm CANN SCREW FASTENER Ti FL THD | 320-40022-03 | Osteocentric Technologies, Inc. | HWC | 00810074304665 |
| 4.0 X 26mm CANN SCREW FASTENER Ti SH THD | 320-40026-01 | Osteocentric Technologies, Inc. | HWC | 00810074303064 |
| 4.0 X 95mm CANN SCREW FASTENER Ti LG THD | 320-40095-02 | Osteocentric Technologies, Inc. | HWC | 00810074303705 |
| 4.0 X 42mm CANN SCREW FASTENER Ti LG THD | 320-40042-02 | Osteocentric Technologies, Inc. | HWC | 00810074303545 |
| 4.0 X 75mm CANN SCREW FASTENER Ti SH THD | 320-40075-01 | Osteocentric Technologies, Inc. | HWC | 00810074303262 |
| 4.0 X 30mm CANN SCREW FASTENER Ti SH THD | 320-40030-01 | Osteocentric Technologies, Inc. | HWC | 00810074303088 |
| 8.0mm Tap, Cann, Hudson-Mod, 100mm | 2004-0021 | Osteocentric Technologies, Inc. | HWX | 00816950027987 |
| 4.0mm Hex Driver, Solid, Hudson-Mod, 235mm | 2004-0006 | Osteocentric Technologies, Inc. | HXX | 00816950027901 |
| Ø8.0 x 60mm x 24mm CANNULATED PARTIAL THREAD | 380-5060-024 | Osteocentric Technologies, Inc. | HWC | 00816950027192 |
| Ø7.0 x 24mm x 90mm CANNULATED PARTIAL THREAD SCREW | 370-5090-024 | Osteocentric Technologies, Inc. | HWC | 00816950026775 |
| 2.8/3.5mm Double Drill Guide | 320-0028 | Osteocentric Technologies, Inc. | FZX | 00810074306317 |