FDA 510(k) Applications Submitted by Medacta International, SA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120024 |
01/03/2012 |
MECTALIF TRANSFORAMINAL |
MEDACTA INTERNATIONAL, SA |
| K100314 |
02/04/2010 |
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US |
MEDACTA INTERNATIONAL, SA |
| K093944 |
12/22/2009 |
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S |
MEDACTA INTERNATIONAL, SA |
| K092265 |
07/29/2009 |
VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS |
MEDACTA INTERNATIONAL, SA |
| K080885 |
03/31/2008 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION |
MEDACTA INTERNATIONAL, SA |
| K090988 |
04/07/2009 |
GMK TOTAL KNEE SYSTEM |
MEDACTA INTERNATIONAL, SA |
| K081023 |
04/10/2008 |
EVOLIS TOTAL KNEE SYSTEM |
MEDACTA INTERNATIONAL, SA |
| K091069 |
04/14/2009 |
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT |
MEDACTA INTERNATIONAL, SA |
| K091967 |
07/01/2009 |
MEDACTA BIPOLAR HEAD |
MEDACTA INTERNATIONAL, SA |
| K102437 |
08/26/2010 |
GMK REVISION KNEE SYSTEM |
MEDACTA INTERNATIONAL, SA |
| K082792 |
09/23/2008 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS |
MEDACTA INTERNATIONAL, SA |
| K083116 |
10/21/2008 |
VERSAFIT CUP DOUBLE MOBILITY SYSTEM |
MEDACTA INTERNATIONAL, SA |
| K103170 |
10/27/2010 |
GMK REVISION KNEE SC LINERS |
MEDACTA INTERNATIONAL, SA |
| K103189 |
10/28/2010 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK |
MEDACTA INTERNATIONAL, SA |
| K073337 |
11/28/2007 |
MECTACER BIOLOX FORTE-FEMORAL HEADS |
MEDACTA INTERNATIONAL, SA |
| K083558 |
12/02/2008 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C |
MEDACTA INTERNATIONAL, SA |
| K093806 |
12/11/2009 |
MYKNEE CUTTING BLOCKS |
MEDACTA INTERNATIONAL, SA |
| K083872 |
12/29/2008 |
IMNS MEDACTA NAVIGATION SYSTEM |
MEDACTA INTERNATIONAL, SA |
| K072857 |
10/05/2007 |
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT |
MEDACTA INTERNATIONAL, SA |
| K210263 |
02/01/2021 |
Mpres Neck Preserving Stem |
MEDACTA INTERNATIONAL, SA |
| K210859 |
03/23/2021 |
NextARÖ Spine Platform |
Medacta International, SA |
| K192967 |
10/23/2019 |
Medacta Shoulder System |
Medacta International, SA |
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