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
76-100 of 184
Cleared Jul 15, 2011
EXACTECH GIBRALT SPINAL SYSTEM
K110197 · MNI
Orthopedic · 172d
Cleared Jun 30, 2011
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655 · ODP
Orthopedic · 197d
Cleared Jun 08, 2011
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE...
K111379 · KWS
Orthopedic · 22d
Cleared May 17, 2011
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
K110706 · KWT
Orthopedic · 64d
Cleared Apr 01, 2011
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE /...
K110708 · PHX
Orthopedic · 18d
Cleared Jan 21, 2011
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
K102870 · MNH
Orthopedic · 113d
Cleared Dec 13, 2010
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
K103419 · KWS
Orthopedic · 21d
Cleared Nov 10, 2010
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD,...
K103012 · LZO
Orthopedic · 29d
Cleared Nov 08, 2010
NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA...
K102487 · LZO
Orthopedic · 70d
Cleared Nov 05, 2010
NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE
K102975 · LPH
Orthopedic · 30d
Cleared Nov 04, 2010
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL...
K102951 · PHX
Orthopedic · 30d
Cleared Sep 21, 2010
EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL...
K101761 · LPH
Orthopedic · 90d
Cleared Sep 02, 2010
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE,...
K093430 · KWS
Orthopedic · 303d
Cleared Aug 02, 2010
EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
K101909 · PHX
Orthopedic · 25d
Cleared Aug 02, 2010
OPTETRAK LOGIC COMBINATION TIBIAL TRAY
K101981 · JWH
Orthopedic · 19d
Cleared May 27, 2010
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER
K093275 · PHX
Orthopedic · 220d
Cleared May 27, 2010
NOVATION CROWN CUP GXL LINERS
K100269 · LPH
Orthopedic · 118d
Cleared May 11, 2010
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
K093978 · HRS
Orthopedic · 138d
Cleared Jan 11, 2010
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES...
K093360 · JWH
Orthopedic · 75d
Cleared Jan 07, 2010
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
K092900 · PHX
Orthopedic · 108d
Cleared Apr 21, 2009
NOVATION CFS PRESS-FIT AND CEMENTED STEMS
K090764 · LWJ
Orthopedic · 29d
Cleared Dec 17, 2008
NOVATION 12/14 CEMENTED FEMORAL STEMS
K083392 · LZO
Orthopedic · 30d
Cleared Oct 10, 2008
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
K082702 · PHX
Orthopedic · 24d
Cleared Sep 02, 2008
OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
K082022 · JWH
Orthopedic · 48d
Cleared May 06, 2008
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
K080980 · MEH
Orthopedic · 29d

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