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
101-125 of 184
Cleared Feb 29, 2008
EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW
K073688 · PHX
Orthopedic · 63d
Cleared Aug 15, 2007
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
K071738 · JWH
Orthopedic · 50d
Cleared Jul 19, 2007
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS
K071676 · KWZ
Orthopedic · 30d
Cleared Jun 07, 2007
OPTECURE
K063685 · MBP
Orthopedic · 177d
Cleared Mar 15, 2007
EXACTECH NOVATION CROWN CUP AND LINERS
K070479 · LZO
Orthopedic · 23d
Cleared Feb 23, 2007
EQUINOXE REVERSE SHOULDER SYSTEM
K063569 · PHX
Orthopedic · 86d
Cleared Nov 29, 2006
NOVATION SPLINED RDD FEMORAL STEMS
K063279 · LZO
Orthopedic · 29d
Cleared Sep 12, 2006
OPTECURE +CCC
K061668 · MBP
Orthopedic · 90d
Cleared Jun 12, 2006
EXACTECH EQUINOXE SHOULDER STEMS
K061454 · HSD
Orthopedic · 18d
Cleared Feb 08, 2006
OPTECURE
K050806 · MBP
Orthopedic · 315d
Cleared Feb 06, 2006
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K060107 · LZO
Orthopedic · 24d
Cleared Dec 27, 2005
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14...
K052787 · LZO
Orthopedic · 85d
Cleared Dec 01, 2005
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
K051858 · LZO
Orthopedic · 146d
Cleared Nov 18, 2005
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K050398 · LZO
Orthopedic · 275d
Cleared Sep 06, 2005
ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE
K051556 · LPH
Orthopedic · 85d
Cleared Jul 19, 2005
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
K051682 · LZO
Orthopedic · 26d
Cleared Jun 21, 2005
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
K051335 · JDI
Orthopedic · 29d
Cleared Dec 28, 2004
CEMEX SYSTEM GENTA FAST BONE CEMENT
K043403 · LOD
Orthopedic · 18d
Cleared Nov 09, 2004
NOVATION 12/14 PRESS-FIT FEMORAL STEM
K042842 · LZO
Orthopedic · 26d
Cleared Oct 26, 2004
EXACTECH EQUINOXE SHOULDER SYSTEM
K042021 · KWS
Orthopedic · 90d
Cleared Oct 04, 2004
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
K040601 · KWZ
Orthopedic · 210d
Cleared Oct 01, 2004
EXACTECH OPTETRAK UNICONDYLAR KNEE
K040889 · HRY
Orthopedic · 179d
Cleared Sep 10, 2004
EXACTECH 12/14 TOTAL HIP SYSTEM
K041906 · LPH
Orthopedic · 57d
Cleared Jun 17, 2004
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
K040755 · MQV
Orthopedic · 85d
Cleared Jun 04, 2004
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
K040613 · MEH
Orthopedic · 87d

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