FDA 510(k) Applications Submitted by GARY J MILLER
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K030236 |
01/23/2003 |
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT |
EXACTECH, INC. |
K030686 |
03/05/2003 |
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT |
EXACTECH, INC. |
K040601 |
03/08/2004 |
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS |
EXACTECH, INC. |
K040613 |
03/09/2004 |
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS |
EXACTECH, INC. |
K040889 |
04/05/2004 |
EXACTECH OPTETRAK UNICONDYLAR KNEE |
EXACTECH, INC. |
K021765 |
05/29/2002 |
CEMENT RESTRICTOR, SMALL AND LARGE |
EXACTECH, INC. |
K001853 |
06/19/2000 |
SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1 |
MEDTECH SYSTEMS, INC. |
K042021 |
07/28/2004 |
EXACTECH EQUINOXE SHOULDER SYSTEM |
EXACTECH, INC. |
K033596 |
11/14/2003 |
CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT |
EXACTECH, INC. |
K033883 |
12/15/2003 |
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI |
EXACTECH, INC. |
K010120 |
01/16/2001 |
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S |
EXACTECH, INC. |
K990197 |
01/20/1999 |
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM |
EXACTECH, INC. |
K000242 |
01/27/2000 |
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE |
EXACTECH, INC. |
K000943 |
03/23/2000 |
CEMEX SYSTEM GUN APPLICATION VERSION |
EXACTECH, INC. |
K011081 |
04/10/2001 |
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS |
EXACTECH, INC. |
K011218 |
04/20/2001 |
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 |
EXACTECH, INC. |
K031430 |
05/06/2003 |
CEMEX SYSTEM FAST |
EXACTECH, INC. |
K021715 |
05/23/2002 |
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL |
EXACTECH, INC. |
K031841 |
06/16/2003 |
SPACER G TEMPORARY HIP PROSTHESIS |
EXACTECH, INC. |
K011976 |
06/25/2001 |
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) |
EXACTECH, INC. |
K041906 |
07/15/2004 |
EXACTECH 12/14 TOTAL HIP SYSTEM |
EXACTECH, INC. |
K032522 |
08/15/2003 |
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS |
EXACTECH, INC. |
K993082 |
09/15/1999 |
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT |
EXACTECH, INC. |
K032964 |
09/23/2003 |
EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS |
EXACTECH, INC. |
K993736 |
11/04/1999 |
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT |
EXACTECH, INC. |
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