Exactech, Inc. - FDA 510(k) Cleared Devices
185
Total
173
Cleared
0
Denied
184 devices
Cleared
Jul 30, 2014
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
Orthopedic
174d
Cleared
Jul 29, 2014
ALTEON 6.5MM BONE SCREWS
Orthopedic
27d
Cleared
Jun 30, 2014
EXACTECH TAPERED WEDGE FEMORAL STEM
Orthopedic
104d
Cleared
Apr 25, 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
Orthopedic
520d
Cleared
Feb 12, 2014
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
Orthopedic
180d
Cleared
Feb 11, 2014
EQUINOXE EXTRA SHORT HUMERAL HEAD
Orthopedic
32d
Cleared
Nov 26, 2013
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
Orthopedic
204d
Cleared
Oct 11, 2013
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM...
Orthopedic
91d
Cleared
Jul 03, 2013
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID...
Orthopedic
33d
Cleared
May 01, 2013
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE...
Orthopedic
69d
Cleared
Mar 20, 2013
OPTETRAK LOGIC POROUS FEMORAL COMPONENT
Orthopedic
107d
Cleared
Feb 12, 2013
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM...
Orthopedic
229d
Cleared
Jan 16, 2013
NOVATION CROWN CUP LINERS
Orthopedic
252d
Cleared
Jan 10, 2013
OPTETRAK LOGIC CRC TIBIAL INSERT
Orthopedic
71d
Cleared
Dec 06, 2012
EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR...
Orthopedic
244d
Cleared
Nov 27, 2012
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE +...
Orthopedic
144d
Cleared
Nov 20, 2012
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
Orthopedic
211d
Cleared
Oct 11, 2012
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
Orthopedic
29d
Cleared
Oct 01, 2012
NOVATION LPI PRIME FEMORAL STEM
Orthopedic
116d
Cleared
May 31, 2012
OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE...
Orthopedic
30d
Cleared
Mar 16, 2012
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA...
Orthopedic
127d
Cleared
Jan 04, 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
Orthopedic
29d
Cleared
Dec 08, 2011
EXACTECH EQUINOXE CAGE GLENOIDS
Orthopedic
30d
Cleared
Nov 21, 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
Orthopedic
122d
Cleared
Jul 28, 2011
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
Orthopedic
70d
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