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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