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
151-175 of 184
Cleared Aug 16, 2000
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH...
K002141 · LWJ
Orthopedic · 30d
Cleared May 18, 2000
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
K001335 · JDI
Orthopedic · 21d
Cleared Feb 16, 2000
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES...
K000242 · MEH
Orthopedic · 20d
Cleared Jan 20, 2000
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
K993736 · LPH
Orthopedic · 77d
Cleared Nov 19, 1999
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR...
K993082 · LPH
Orthopedic · 65d
Cleared Feb 04, 1999
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
K990197 · MEH
Orthopedic · 15d
Cleared Dec 27, 1996
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
K964262 · JDI
Orthopedic · 63d
Cleared Nov 14, 1996
EXACTECH ALL POLY ACETABULAR CUP
K963313 · JDI
Orthopedic · 84d
Cleared Oct 01, 1996
AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM
K961304 · JDI
Orthopedic · 180d
Cleared Aug 08, 1996
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
K962002 · JDG
Orthopedic · 78d
Cleared Apr 23, 1996
EXACTECH STERILE MODULAR DRILL BIT
K960720 · HWE
Orthopedic · 61d
Cleared Mar 27, 1996
OPTEON UNIPOLAR
K960538 · KWL
Orthopedic · 49d
Cleared Feb 26, 1996
OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY
K954208 · JWH
Orthopedic · 172d
Cleared Mar 10, 1995
EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM
K933494 · JWH
Orthopedic · 599d
Cleared Feb 09, 1995
EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY
K932690 · JWH
Orthopedic · 616d
Cleared Jan 17, 1995
EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS
K933610 · JWH
Orthopedic · 539d
Cleared Dec 09, 1994
EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT
K935773 · JWH
Orthopedic · 371d
Cleared Oct 20, 1994
CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
K932776 · JWH
Orthopedic · 499d
Cleared Oct 20, 1994
EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT
K935726 · JWH
Orthopedic · 323d
Cleared Sep 07, 1994
ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT
K936079 · JWH
Orthopedic · 259d
Cleared Jun 14, 1994
EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT
K931617 · LZO
Orthopedic · 438d
Cleared Apr 29, 1994
EXACTECH ALL POLY ACETABULAR CUP
K934253 · JDZ
Orthopedic · 241d
Cleared Oct 27, 1993
EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
K921113 · LPH
Orthopedic · 597d
Cleared Oct 27, 1993
EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR
K921114 · LPH
Orthopedic · 597d
Cleared Jun 15, 1993
EXACTECH FEMORAL STEM
K925201 · JDI
Orthopedic · 242d

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