Exactech, Inc. - FDA 510(k) Cleared Devices
185
Total
173
Cleared
0
Denied
184 devices
Cleared
Jul 15, 2011
EXACTECH GIBRALT SPINAL SYSTEM
Orthopedic
172d
Cleared
Jun 30, 2011
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
Orthopedic
197d
Cleared
Jun 08, 2011
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE...
Orthopedic
22d
Cleared
May 17, 2011
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
Orthopedic
64d
Cleared
Apr 01, 2011
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE /...
Orthopedic
18d
Cleared
Jan 21, 2011
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
Orthopedic
113d
Cleared
Dec 13, 2010
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
Orthopedic
21d
Cleared
Nov 10, 2010
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD,...
Orthopedic
29d
Cleared
Nov 08, 2010
NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA...
Orthopedic
70d
Cleared
Nov 05, 2010
NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE
Orthopedic
30d
Cleared
Nov 04, 2010
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL...
Orthopedic
30d
Cleared
Sep 21, 2010
EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL...
Orthopedic
90d
Cleared
Sep 02, 2010
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE,...
Orthopedic
303d
Cleared
Aug 02, 2010
EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
Orthopedic
25d
Cleared
Aug 02, 2010
OPTETRAK LOGIC COMBINATION TIBIAL TRAY
Orthopedic
19d
Cleared
May 27, 2010
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER
Orthopedic
220d
Cleared
May 27, 2010
NOVATION CROWN CUP GXL LINERS
Orthopedic
118d
Cleared
May 11, 2010
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
Orthopedic
138d
Cleared
Jan 11, 2010
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES...
Orthopedic
75d
Cleared
Jan 07, 2010
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
Orthopedic
108d
Cleared
Apr 21, 2009
NOVATION CFS PRESS-FIT AND CEMENTED STEMS
Orthopedic
29d
Cleared
Dec 17, 2008
NOVATION 12/14 CEMENTED FEMORAL STEMS
Orthopedic
30d
Cleared
Oct 10, 2008
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
Orthopedic
24d
Cleared
Sep 02, 2008
OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
Orthopedic
48d
Cleared
May 06, 2008
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
Orthopedic
29d
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