FDA 510(k) Applications Submitted by AMENDIA, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160924 |
04/04/2016 |
Amendia Interbody Fusion Devices |
AMENDIA, INC. |
| K150395 |
02/18/2015 |
Omega LIF System |
AMENDIA, INC. |
| K151310 |
05/18/2015 |
Amendia Interbody Fusion Devices |
AMENDIA, INC. |
| K151322 |
05/18/2015 |
Amendia Interbody Fusion Devices |
AMENDIA, INC. |
| K161842 |
07/05/2016 |
Overwatch Spine System |
Amendia, Inc. |
| K152460 |
08/28/2015 |
Rectangular Corpectomy Cage |
Amendia, Inc. |
| K132925 |
09/18/2013 |
SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK |
AMENDIA, INC. |
| K160291 |
02/03/2016 |
Optimus ALIF System |
Amendia, Inc. |
| K152920 |
10/02/2015 |
Savannah-T« Pedicle Screw System |
AMENDIA, INC. |
| K152972 |
10/08/2015 |
Amendia Stand-Alone Cervical System |
AMENDIA, INC. |
| K153152 |
11/02/2015 |
Syzygy Stabilization System |
AMENDIA, INC. |
| K113011 |
10/11/2011 |
SPARTAN S3 FACET SYSTEM |
AMENDIA, INC. |
| K092568 |
08/20/2009 |
SPARTAN S3 FACET SYSTEM |
AMENDIA, INC. |
| K100265 |
01/29/2010 |
DIAMOND ANTERIOR CERVICAL PLATE SYSTEM |
AMENDIA, INC. |
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