Exactech, Inc. - FDA 510(k) Cleared Devices
185
Total
173
Cleared
0
Denied
184 devices
Cleared
May 28, 2004
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
Orthopedic
287d
Cleared
May 10, 2004
CEMEX GENTA BONE CEMENT
Orthopedic
178d
Cleared
Feb 27, 2004
EXACTECH RESORBABLE BONE PASTE
Orthopedic
779d
Cleared
Feb 13, 2004
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED...
Orthopedic
60d
Cleared
Jan 22, 2004
SPACER G TEMPORARY HIP PROSTHESIS
Orthopedic
220d
Cleared
Nov 13, 2003
EXACTECH 12/14 ALUMINA FEMORAL HEAD
Orthopedic
51d
Cleared
Sep 23, 2003
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6...
Orthopedic
29d
Cleared
May 22, 2003
CEMEX SYSTEM FAST
Orthopedic
16d
Cleared
Apr 02, 2003
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
Orthopedic
28d
Cleared
Feb 20, 2003
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
Orthopedic
28d
Cleared
Nov 13, 2002
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
Orthopedic
14d
Cleared
Oct 17, 2002
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
Orthopedic
23d
Cleared
Aug 16, 2002
CEMENT RESTRICTOR, SMALL AND LARGE
Orthopedic
79d
Cleared
Jun 12, 2002
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
Orthopedic
20d
Cleared
Feb 27, 2002
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
Orthopedic
30d
Cleared
Dec 05, 2001
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
Orthopedic
70d
Cleared
Aug 29, 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
Orthopedic
26d
Cleared
Jul 31, 2001
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
Orthopedic
13d
Cleared
Jul 16, 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
Orthopedic
21d
Cleared
May 16, 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
Orthopedic
26d
Cleared
Apr 24, 2001
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
Orthopedic
14d
Cleared
Mar 13, 2001
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
Orthopedic
28d
Cleared
Feb 09, 2001
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH...
Orthopedic
24d
Cleared
Feb 08, 2001
CEMEX SYSTEM GUN APPLICATION VERSION
Orthopedic
322d
Cleared
Feb 05, 2001
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
Orthopedic
26d
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