FDA 510(k) Applications Submitted by Kristi Vondra
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090048 |
01/07/2009 |
ASFORA BULLET CAGE SYSTEM |
MEDICAL DESIGNS, LLC |
| K170475 |
02/16/2017 |
SICAGEÖ System |
Sicage LLc |
| K121148 |
04/16/2012 |
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D |
MEDICAL DESIGN LLC. |
| K181591 |
06/18/2018 |
Fixated Asfora BULLET CAGE« (FABC) |
Medical Designs, LLC |
| K122497 |
08/16/2012 |
ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM |
MEDICAL DESIGN LLC. |
| K182352 |
08/29/2018 |
SP-LINKÖ System |
Medical Designs LLC |
| K112648 |
09/12/2011 |
ASFORA BULLET CAGE |
MEDICAL DESIGNS, LLC |
| K143688 |
12/24/2014 |
ASFORA ANTERIOR CERVICAL PLATE SYSTEM |
MEDICAL DESIGNS, LLC |
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