FDA 510(k) Applications Submitted by AMITA SHAH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160025 |
01/06/2016 |
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System |
CONFORMIS, INC. |
| K120068 |
01/09/2012 |
CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) |
CONFORMIS, INC. |
| K140423 |
02/18/2014 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K140833 |
04/02/2014 |
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K131019 |
04/12/2013 |
ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K161366 |
05/17/2016 |
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) |
CONFORMIS, INC. |
| K131467 |
05/21/2013 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K161668 |
06/16/2016 |
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) |
CONFORMIS, INC. |
| K191731 |
06/28/2019 |
Instylla Microcatheter |
Instylla, Inc. |
| K142161 |
08/06/2014 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K092441 |
08/10/2009 |
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
| K132640 |
08/23/2013 |
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K142404 |
08/27/2014 |
iTotal Posterior Stabilized (PS) Knee Replacement System |
ConforMIS Inc. |
| K152704 |
09/21/2015 |
iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System |
CONFORMIS, INC |
| K122991 |
09/26/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K162719 |
09/29/2016 |
iTotal« Hip Replacement System |
ConforMIS, Inc. |
| K153217 |
11/05/2015 |
ConforMIS iTotal Posterior Stabilized Knee Replacement System |
ConforMIS, Inc. |
| K133560 |
11/20/2013 |
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM |
CONFORMIS, INC. |
| K153721 |
12/28/2015 |
iTotal Cruciate Retaining (CR) Knee Replacement System |
CONFORMIS, INC. |
| K093513 |
11/13/2009 |
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
| K120316 |
02/01/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K121974 |
07/05/2012 |
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K111916 |
07/06/2011 |
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K122033 |
07/11/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K122870 |
09/19/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K112780 |
09/26/2011 |
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K103117 |
10/21/2010 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K113378 |
11/16/2011 |
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
| K094050 |
12/31/2009 |
ITOTAL CR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
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