FDA 510(k) Applications Submitted by Exactech, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K071738 06/26/2007 EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER EXACTECH, INC.
K063569 11/29/2006 EQUINOXE REVERSE SHOULDER SYSTEM EXACTECH, INC.
K122798 09/12/2012 INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL EXACTECH, INC.
K101761 06/23/2010 EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 EXACTECH, INC.
K150130 01/21/2015 Ascendant TM Cervical Spacer System EXACTECH, INC.
K150152 01/23/2015 The Octane Straight Intervertebral Fusion Device, Ti Coated EXACTECH, INC.
K160697 03/14/2016 Gibralt« Spine System and Gibralt« Occipital Spine System Exactech, Inc.
K143576 12/17/2014 Exactech Ambassador EXACTECH, INC.
K051556 06/13/2005 ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE EXACTECH, INC.
K030236 01/23/2003 ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT EXACTECH, INC.
K030686 03/05/2003 OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT EXACTECH, INC.
K040601 03/08/2004 EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS EXACTECH, INC.
K040613 03/09/2004 EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS EXACTECH, INC.
K040889 04/05/2004 EXACTECH OPTETRAK UNICONDYLAR KNEE EXACTECH, INC.
K021765 05/29/2002 CEMENT RESTRICTOR, SMALL AND LARGE EXACTECH, INC.
K042021 07/28/2004 EXACTECH EQUINOXE SHOULDER SYSTEM EXACTECH, INC.
K033596 11/14/2003 CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT EXACTECH, INC.
K033883 12/15/2003 OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI EXACTECH, INC.
K010120 01/16/2001 MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S EXACTECH, INC.
K990197 01/20/1999 MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM EXACTECH, INC.
K000242 01/27/2000 ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE EXACTECH, INC.
K000943 03/23/2000 CEMEX SYSTEM GUN APPLICATION VERSION EXACTECH, INC.
K011081 04/10/2001 ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS EXACTECH, INC.
K011218 04/20/2001 ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 EXACTECH, INC.
K031430 05/06/2003 CEMEX SYSTEM FAST EXACTECH, INC.
K021715 05/23/2002 CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL EXACTECH, INC.
K031841 06/16/2003 SPACER G TEMPORARY HIP PROSTHESIS EXACTECH, INC.
K011976 06/25/2001 OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) EXACTECH, INC.
K041906 07/15/2004 EXACTECH 12/14 TOTAL HIP SYSTEM EXACTECH, INC.
K032522 08/15/2003 TECRES SPACER-K TEMPORARY KNEE PROSTHESIS EXACTECH, INC.
K993082 09/15/1999 EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT EXACTECH, INC.
K032964 09/23/2003 EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS EXACTECH, INC.
K993736 11/04/1999 EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT EXACTECH, INC.
K121989 07/06/2012 OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, EXACTECH, INC.
K071676 06/19/2007 EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS EXACTECH, INC.
K082022 07/16/2008 OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ EXACTECH, INC.
K093430 11/03/2009 EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. EXACTECH, INC.
K073688 12/28/2007 EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW EXACTECH, INC.
K100269 01/29/2010 NOVATION CROWN CUP GXL LINERS EXACTECH, INC.
K110706 03/14/2011 EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD EXACTECH, INC.
K111379 05/17/2011 EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT EXACTECH, INC.
K101909 07/08/2010 EXACTECH EQUINOXE, PLATFORM FRACTURE STEM EXACTECH, INC.
K102951 10/05/2010 EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) EXACTECH, INC.
K083392 11/17/2008 NOVATION 12/14 CEMENTED FEMORAL STEMS EXACTECH, INC.
K212356 07/29/2021 Exactech« Equinoxe« Laser Cage Glenoid Exactech, Inc.
K110708 03/14/2011 EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... EXACTECH, INC.
K121067 04/06/2012 EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE EXACTECH, INC.
K121220 04/23/2012 EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT EXACTECH, INC.
K121392 05/09/2012 NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE EXACTECH, INC.
K103012 10/12/2010 EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS EXACTECH, INC.
K093275 10/19/2009 EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER EXACTECH, INC.
K010081 01/10/2001 ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS EXACTECH, INC.
K010434 02/13/2001 OPTETRAK B-SERIES TOTAL KNEE SYSTEM EXACTECH, INC.
K050398 02/16/2005 EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS EXACTECH, INC.
K001335 04/27/2000 ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED EXACTECH, INC.
K051858 07/08/2005 ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM EXACTECH, INC.
K002141 07/17/2000 ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT EXACTECH, INC.
K042842 10/14/2004 NOVATION 12/14 PRESS-FIT FEMORAL STEM EXACTECH, INC.
K023646 10/30/2002 EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM EXACTECH, INC.
K043403 12/10/2004 CEMEX SYSTEM GENTA FAST BONE CEMENT EXACTECH, INC.
K190890 04/05/2019 Exactech Alteon Modular Dual Mobility (MDM) System Exactech, Inc.
K060107 01/13/2006 MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS EXACTECH, INC.
K070479 02/20/2007 EXACTECH NOVATION CROWN CUP AND LINERS EXACTECH, INC.
K051335 05/23/2005 ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS EXACTECH, INC.
K061454 05/25/2006 EXACTECH EQUINOXE SHOULDER STEMS EXACTECH, INC.
K061668 06/14/2006 OPTECURE +CCC EXACTECH, INC.
K051682 06/23/2005 EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM EXACTECH, INC.
K052787 10/03/2005 ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) EXACTECH, INC.
K063279 10/31/2006 NOVATION SPLINED RDD FEMORAL STEMS EXACTECH, INC.
K063685 12/12/2006 OPTECURE; OPTECURE + CCC EXACTECH, INC.
K963313 08/22/1996 EXACTECH ALL POLY ACETABULAR CUP EXACTECH, INC.
K964262 10/25/1996 EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD EXACTECH, INC.
K960538 02/07/1996 OPTEON UNIPOLAR EXACTECH, INC.
K960720 02/22/1996 EXACTECH STERILE MODULAR DRILL BIT EXACTECH, INC.
K961304 04/04/1996 AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM EXACTECH, INC.
K962002 05/22/1996 AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM EXACTECH, INC.
K954208 09/07/1995 OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY EXACTECH, INC.
K023186 09/24/2002 OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY EXACTECH, INC.
K032606 08/25/2003 OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS EXACTECH, INC.
K182346 08/28/2018 TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws Exactech, Inc.
K141129 05/01/2014 EXACTECH CERVICAL SPACER SYSTEM EXACTECH, INC.
K140063 01/10/2014 EQUINOXE EXTRA SHORT HUMERAL HEAD EXACTECH, INC.
K150066 01/13/2015 Exactech Alteon Monobloc Revision Stem EXACTECH, INC.
K140302 02/06/2014 OPTETRAK LOGIC POROUS FEMORAL COMPONENTS EXACTECH, INC.
K130434 02/21/2013 OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC EXACTECH, INC.
K150890 04/02/2015 Exactech Optetrak Logic CC EXACTECH, INC.
K171045 04/07/2017 Exactech« TruliantÖ Line Extensions Exactech, Inc.
K121307 05/01/2012 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ EXACTECH, INC.
K111400 05/19/2011 OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT EXACTECH, INC.
K131575 05/31/2013 EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT EXACTECH, INC.
K181794 07/05/2018 Truliant Porous Femoral Components Exactech, Inc.
K132161 07/12/2013 OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS EXACTECH, INC.
K101981 07/14/2010 OPTETRAK LOGIC COMBINATION TIBIAL TRAY EXACTECH, INC.
K152170 08/04/2015 Exactech Optetrak Logic Enhanced Assembly EXACTECH, INC.
K132582 08/16/2013 EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM EXACTECH, INC.
K093360 10/28/2009 OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T EXACTECH, INC.
K123342 10/31/2012 OPTETRAK LOGIC CRC TIBIAL INSERT EXACTECH, INC.
K113309 11/08/2011 EXACTECH EQUINOXE CAGE GLENOIDS EXACTECH, INC.
K123607 11/21/2012 OCTANE ELEVATE SPINAL IMPLANT SYSTEM EXACTECH, INC.
K103419 11/22/2010 EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM EXACTECH, INC.
K123687 12/03/2012 OPTETRAK LOGIC POROUS FEMORAL COMPONENT EXACTECH, INC.
K103655 12/15/2010 OCTANE-C INTERBODY FUSION DEVICE SYSTEM EXACTECH, INC.
K040755 03/24/2004 EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE EXACTECH, INC.
K050806 03/30/2005 OPTECURE EXACTECH, INC.
K012251 07/18/2001 OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES EXACTECH, INC.
K012493 08/03/2001 ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 EXACTECH, INC.
K013211 09/26/2001 MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS EXACTECH, INC.
K020291 01/28/2002 EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER EXACTECH, INC.
K082702 09/16/2008 EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY EXACTECH, INC.
K093978 12/24/2009 EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM EXACTECH, INC.
K140674 03/18/2014 EXACTECH TAPERED WEDGE FEMORAL STEM EXACTECH, INC.
K131298 05/06/2013 EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM EXACTECH, INC.
K103699 12/20/2010 EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC EXACTECH, INC.
K173583 11/20/2017 Exactech« Novation« and AcuMatch« E-HXL Acetabular Liners Exactech, Inc.
K020078 01/09/2002 EXACTECH RESORBABLE BONE PASTE EXACTECH, INC.
K090764 03/23/2009 NOVATION CFS PRESS-FIT AND CEMENTED STEMS EXACTECH, INC.
K092900 09/21/2009 EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM EXACTECH, INC.
K150458 02/23/2015 Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere EXACTECH, INC.
K141797 07/02/2014 ALTEON 6.5MM BONE SCREWS EXACTECH, INC.
K141821 07/07/2014 ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET EXACTECH, INC.
K141960 07/18/2014 Exactech« Novation« Crown Cup« EXACTECH, INC.
K143659 12/23/2014 Equinoxe Mega Prosthesis EXACTECH, INC.
K110197 01/24/2011 EXACTECH GIBRALT SPINAL SYSTEM EXACTECH, INC.
K121684 06/07/2012 NOVATION LPI PRIME FEMORAL STEM EXACTECH, INC.
K121877 06/28/2012 GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES EXACTECH, INC.
K112097 07/22/2011 GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 EXACTECH, INC.
K102487 08/30/2010 NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 EXACTECH, INC.
K102870 09/30/2010 EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM EXACTECH, INC.
K102975 10/06/2010 NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE EXACTECH, INC.
K113320 11/10/2011 NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 EXACTECH, INC.
K113609 12/06/2011 NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 EXACTECH, INC.
K080980 04/07/2008 EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS EXACTECH, INC.
K181532 06/11/2018 Exactech Alteon Monobloc Revision Stem Exactech, Inc.
K192097 08/05/2019 Exactech« Equinoxe« Stemless Humeral Components Exactech, Inc.
K182462 09/10/2018 Exactech Alteon Highly Polished Femoral Stem Exactech, Inc.
K182536 09/14/2018 Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap Exactech, Inc.


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