FDA 510(k) Applications Submitted by Karla Schaffner
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090228 |
01/30/2009 |
ROC LUMBAR PLATING SYSTEM |
ALPHATEC SPINE, INC. |
| K210766 |
03/15/2021 |
AcQMap 3D Imaging and Mapping Catheter, Model 900009 |
Acutus Medical, Inc. |
| K231091 |
04/17/2023 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical Inc |
| K111076 |
04/18/2011 |
SOLANAS AVALON POSTERIOR FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
| K101255 |
05/04/2010 |
ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM |
ALPHATEC SPINE, INC. |
| K201341 |
05/20/2020 |
AcQMap 3D Imaging and Mapping Catheter |
Acutus Medical, Inc. |
| K191392 |
05/24/2019 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
| K102820 |
09/28/2010 |
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
ALPHATEC SPINE, INC. |
| K193013 |
10/29/2019 |
AcQMap High Resolution Imaging and Mapping System |
Acutus Medical, Inc. |
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