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
51-75 of 184
Cleared Jul 30, 2014
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
K140302 · MBH
Orthopedic · 174d
Cleared Jul 29, 2014
ALTEON 6.5MM BONE SCREWS
K141797 · LPH
Orthopedic · 27d
Cleared Jun 30, 2014
EXACTECH TAPERED WEDGE FEMORAL STEM
K140674 · LZO
Orthopedic · 104d
Cleared Apr 25, 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · MAX
Orthopedic · 520d
Cleared Feb 12, 2014
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
K132582 · OVE
Orthopedic · 180d
Cleared Feb 11, 2014
EQUINOXE EXTRA SHORT HUMERAL HEAD
K140063 · KWS
Orthopedic · 32d
Cleared Nov 26, 2013
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
K131298 · HSD
Orthopedic · 204d
Cleared Oct 11, 2013
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM...
K132161 · JWH
Orthopedic · 91d
Cleared Jul 03, 2013
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID...
K131575 · PHX
Orthopedic · 33d
Cleared May 01, 2013
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE...
K130434 · MAX
Orthopedic · 69d
Cleared Mar 20, 2013
OPTETRAK LOGIC POROUS FEMORAL COMPONENT
K123687 · JWH
Orthopedic · 107d
Cleared Feb 12, 2013
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM...
K121877 · KWP
Orthopedic · 229d
Cleared Jan 16, 2013
NOVATION CROWN CUP LINERS
K121392 · LZO
Orthopedic · 252d
Cleared Jan 10, 2013
OPTETRAK LOGIC CRC TIBIAL INSERT
K123342 · JWH
Orthopedic · 71d
Cleared Dec 06, 2012
EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR...
K121067 · PHX
Orthopedic · 244d
Cleared Nov 27, 2012
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE +...
K121989 · MQV
Orthopedic · 144d
Cleared Nov 20, 2012
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
K121220 · KWS
Orthopedic · 211d
Cleared Oct 11, 2012
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
K122798 · LPH
Orthopedic · 29d
Cleared Oct 01, 2012
NOVATION LPI PRIME FEMORAL STEM
K121684 · LPH
Orthopedic · 116d
Cleared May 31, 2012
OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE...
K121307 · JWH
Orthopedic · 30d
Cleared Mar 16, 2012
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA...
K113320 · MEH
Orthopedic · 127d
Cleared Jan 04, 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
K113609 · LPH
Orthopedic · 29d
Cleared Dec 08, 2011
EXACTECH EQUINOXE CAGE GLENOIDS
K113309 · KWS
Orthopedic · 30d
Cleared Nov 21, 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · MRW
Orthopedic · 122d
Cleared Jul 28, 2011
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
K111400 · JWH
Orthopedic · 70d

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