FDA 510(k) Applications Submitted by ROXANNE DUBOIS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070496 |
02/20/2007 |
ADVACOAT SINUS GEL AND STENT |
CARBYLAN BIOSURGERY |
| K160652 |
03/08/2016 |
iFUSE Implant System |
SI-BONE, INC. |
| K150714 |
03/19/2015 |
SI-BONE iFuse Implant System |
SI-BONE, Inc. |
| K150875 |
04/01/2015 |
iFuse Implant System |
SI-BONE, Inc. |
| K141049 |
04/23/2014 |
IFUSE IMPLANT SYSTEM |
SI-BONE, INC. |
| K151718 |
06/25/2015 |
iFuse Implant System |
SI-BONE, INC. |
| K161893 |
07/11/2016 |
Neuromonitoring Kit |
SI-BONE, INC. |
| K172268 |
07/27/2017 |
iFuse Implant System- iFuse Navigation |
SI-BONE, Inc. |
| K152681 |
09/18/2015 |
iFuse Implant System(R) |
SI-BONE, INC. |
| K162733 |
09/29/2016 |
iFuse Implant System« - iFuse-3D implant |
SI-BONE, INC. |
| K182983 |
10/29/2018 |
iFuse Implant System« |
SI-BONE, Inc. |
| K063308 |
11/02/2006 |
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 |
CARBYLAN BIOSURGERY |
|
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