FDA 510(k) Applications Submitted by Ronald K. Smith
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240685 |
03/12/2024 |
Salvo« Spine System |
Spine Wave, Inc. |
| K251131 |
04/11/2025 |
Annex« 2 Adjacent Level System |
Spine Wave, Inc. |
| K243514 |
11/13/2024 |
Salvo« Robotic Navigation Instruments |
Spine Wave, Inc. |
| K070245 |
01/25/2007 |
CAPSURE PEDICLE SCREW SYSTEM |
SPINE WAVE, INC. |
| K962564 |
07/01/1996 |
RICHARDS TOTAL/PARTIAL PROSTHESIS |
GYRUS ENT L.L.C. |
| K151813 |
07/02/2015 |
Sniper Spine System |
SPINE WAVE, INC. |
| K222362 |
08/04/2022 |
Salvo« Spine System |
Spine Wave, Inc. |
| K052670 |
09/27/2005 |
STAXX XD SYSTEM |
SPINE WAVE, INC. |
| K003201 |
10/12/2000 |
STEALTHSTATION TREATMENT GUIDANCE PLATFORM |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
| K033303 |
10/14/2003 |
WAFER SYSTEM |
SPINE WAVE, INC. |
| K053336 |
12/01/2005 |
STAXX FX SYSTEM |
SPINE WAVE, INC. |
| K063606 |
12/01/2006 |
MODIFICATION TO STAXX FX SYSTEM |
SPINE WAVE, INC. |
| K955552 |
12/05/1995 |
EXPRESSAIRE TORUNIQUET SYSTEM |
SMITH & NEPHEW RICHARDS, INC. |
| K231275 |
05/02/2023 |
ExceedÖ Biplanar Expandable Interbody System |
Spine Wave, Inc. |
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