Medical Device Manufacturer · US , Gainesville , FL

Exactech, Inc. - FDA 510(k) Cleared Devices

185 submissions · 173 cleared · Since 1986
185
Total
173
Cleared
0
Denied
184 devices
126-150 of 184
Cleared May 28, 2004
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
K032522 · JWH
Orthopedic · 287d
Cleared May 10, 2004
CEMEX GENTA BONE CEMENT
K033596 · LOD
Orthopedic · 178d
Cleared Feb 27, 2004
EXACTECH RESORBABLE BONE PASTE
K020078 · MQV
Orthopedic · 779d
Cleared Feb 13, 2004
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED...
K033883 · JWH
Orthopedic · 60d
Cleared Jan 22, 2004
SPACER G TEMPORARY HIP PROSTHESIS
K031841 · KWL
Orthopedic · 220d
Cleared Nov 13, 2003
EXACTECH 12/14 ALUMINA FEMORAL HEAD
K032964 · LPH
Orthopedic · 51d
Cleared Sep 23, 2003
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6...
K032606 · JWH
Orthopedic · 29d
Cleared May 22, 2003
CEMEX SYSTEM FAST
K031430 · LOD
Orthopedic · 16d
Cleared Apr 02, 2003
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
K030686 · JWH
Orthopedic · 28d
Cleared Feb 20, 2003
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
K030236 · LPH
Orthopedic · 28d
Cleared Nov 13, 2002
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
K023646 · JDI
Orthopedic · 14d
Cleared Oct 17, 2002
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
K023186 · JWH
Orthopedic · 23d
Cleared Aug 16, 2002
CEMENT RESTRICTOR, SMALL AND LARGE
K021765 · JDK
Orthopedic · 79d
Cleared Jun 12, 2002
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
K021715 · LOD
Orthopedic · 20d
Cleared Feb 27, 2002
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
K020291 · JDI
Orthopedic · 30d
Cleared Dec 05, 2001
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
K013211 · KWY
Orthopedic · 70d
Cleared Aug 29, 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K012493 · JDI
Orthopedic · 26d
Cleared Jul 31, 2001
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
K012251 · JWH
Orthopedic · 13d
Cleared Jul 16, 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
K011976 · JWH
Orthopedic · 21d
Cleared May 16, 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218 · JDI
Orthopedic · 26d
Cleared Apr 24, 2001
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
K011081 · LPH
Orthopedic · 14d
Cleared Mar 13, 2001
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
K010434 · JWH
Orthopedic · 28d
Cleared Feb 09, 2001
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH...
K010120 · LPH
Orthopedic · 24d
Cleared Feb 08, 2001
CEMEX SYSTEM GUN APPLICATION VERSION
K000943 · LOD
Orthopedic · 322d
Cleared Feb 05, 2001
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
K010081 · KWY
Orthopedic · 26d

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