FDA 510(k) Applications Submitted by JOE W SOWARD
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150125 |
01/20/2015 |
Elite Nitinol Fixation System |
BioMedical Enterprises, Inc. |
| K131640 |
06/04/2013 |
SMOOTH OR THREADED METALLIC BONE FASTENER |
BIOMEDICAL ENT., INC. |
| K142292 |
08/18/2014 |
Speed, Speed Shift, Speed Titan, Speed Arc |
BioMedical Enterprises, Inc. |
| K143023 |
10/21/2014 |
Nitinol Compression Plating System |
BioMedical Enterprises, Inc. |
| K133270 |
10/23/2013 |
SPEED ARC |
BIOMEDICAL ENTERPRISES, INC |
| K133520 |
11/15/2013 |
HAMMERLOCK 2 |
BIOMEDICAL ENTERPRISES, INC |
| K133780 |
12/12/2013 |
SPEED XL |
BIOMEDICAL ENT., INC. |
| K153573 |
12/15/2015 |
Converge |
BIOMEDICAL ENTERPRISES, INC |
| K133844 |
12/18/2013 |
SPEED TRIAD |
BIOMEDICAL ENT., INC. |
| K124022 |
12/28/2012 |
SPEED SHIFT |
BIOMEDICAL ENTERPRISES, INC |
| K091951 |
07/01/2009 |
HAMMERLOCK |
BIOMEDICAL ENT., INC. |
| K102107 |
07/27/2010 |
OSSTAPLE CHILL |
BIOMEDICAL ENT., INC. |
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