FDA.report

EXACTECH, INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
10386711038671EXACTECH, INC.1Y2026-01-012320 N.W. 66TH CT. GAINESVILLE FL US 32653

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
288151181187016P050039NOVATION CERAMIC ARTICULATION HIP SYSTEMMRA2007-07-05
288151919909775K993736EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENTLPH2000-01-20
288151350753352K993082EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENTLPH1999-11-19
288151293322050K990197MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEMMEH1999-02-04
288151797250803K964262EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEADJDI1996-12-27
288151247180120K963313EXACTECH ALL POLY ACETABULAR CUPJDI1996-11-14
288152054359511K962002AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEMJDG1996-08-08
288151947982667K961304AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEMJDI1996-10-01
288151356702894K960720EXACTECH STERILE MODULAR DRILL BITHWE1996-04-23
288151603764380K960538OPTEON UNIPOLARKWL1996-03-27
288151468460052K954208OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLYJWH1996-02-26
288151000727852K936079ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENTJWH1994-09-07
288151541474023K935773EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENTJWH1994-12-09
288151096500355K935726EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENTJWH1994-10-20
288151106435952K934253EXACTECH ALL POLY ACETABULAR CUPJDZ1994-04-29
288151659120442K933933CEBOPLANEHTZ1994-04-15
288151308219261K933610EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTSJWH1995-01-17
288151508725190K933494EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEMJWH1995-03-10
288151661664803K932776CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTSJWH1994-10-20
288151971748515K932690EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SYJWH1995-02-09
288151714770411K931617EXACTECH ZIRAMIC FEMORAL HEAD COMPONENTLZO1994-06-14
288151332239559K925201EXACTECH FEMORAL STEMJDI1993-06-15
288152003461553K921114EXACTECH MCS POROUS COATED TOTAL HIP ACETABULARLPH1993-10-27
288152069178745K921113EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEMLPH1993-10-27
288151024923024K914574EXACTECH CERAMIC FEMORAL HEAD COMPONENTLZO1992-01-13
288151250234406K905580TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND COHSD1991-03-12
288151537643454K905577EXACTECH HUMERAL SHOULDER PROSTHESISHSD1991-03-12
288151920989204K905370EXACTECH BIPOLAR HIP PROSTHESISKWY1991-02-27
288151233578722K901297EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMPJDI1990-05-02
288151790929966K896601EXACTECH BONE SCREWHWC1989-12-06
288151087165798K895607POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENTJDL1989-11-17
288151770007014K862234EXACTECH TOTAL HIP SYSTEMJDI1986-10-15
288151669027661K243839Alteon® HA Femoral StemsMEH2025-03-10
288151346532935K243275Equinoxe® Scapula Fracture SystemHRS2025-06-26
288152064552740K240393Exactech® TRULIANT® Knee SystemMBH2024-10-03
288151042344441K233482Equinoxe® Central Screw Baseplate SystemPHX2024-07-18
288151834561417K232002Vantage® Total Ankle SystemHSN2023-09-11
288151954650629K230717Exactech® Vantage® Total Ankle SystemHSN2023-10-12
288151360260552K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsHRS2023-09-25
288151949913731K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysPHX2023-09-14
288151642019336K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasJWH2023-07-17
288151032999942K221323Exactech® Alteon® Short Tapered WedgeLZO2023-05-19
288151966554245K212356Exactech® Equinoxe® Laser Cage GlenoidKWS2022-03-04
288151524112688K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresPHX2020-02-20
288151521984298K192097Exactech® Equinoxe® Stemless Humeral ComponentsPKC2020-04-29
288151546282390K191561Exactech Equinoxe Humeral Augmented TraysPHX2019-08-20
288151035293568K183343Vantage Total Ankle Flat Cut Talar ComponentsHSN2019-04-01
288151556526053K182991EPIC Extremity Fusion Plate SystemHRS2019-02-13
288151111989725K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking CapPHX2018-10-12
288151293763899K182502Alteon Acetabular Cup SystemLPH2019-03-13
288151899838950K182462Exactech Alteon Highly Polished Femoral StemLZO2018-11-08
288151233108151K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsMBH2018-11-26
288151908317774K181794Truliant Porous Femoral ComponentsMBH2018-09-28
288151646933207K181532Exactech Alteon Monobloc Revision StemLZO2018-09-04
288151381863468K180632Exactech Equinoxe Small Reverse Shoulder SystemPHX2018-07-25
288151287946268K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersOQI2018-03-12
288151962109222K173388Exactech Equinoxe Stemless ShoulderPKC2018-03-09
288151300646188K172441EPIC Extremity Fracture Plate SystemHRS2017-11-06
288151680917011K171045Exactech® Truliant™ Line ExtensionsJWH2017-04-28
288151068477114K170240Truliant Femoral ComponentsJWH2017-02-23
288151297928860K163226EPIC Extremely Small StapleJDR2017-05-16
288151916865233K163038EPIC Extremity Snap-Off ScrewHWC2017-02-28
288151972835693K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesKWT2017-02-27
288151799778263K162732Exactech® Alteon® HA Femoral StemMEH2017-04-26
288151159309774K162726Exactech® Equinoxe® Preserve StemPHX2017-02-01
288151373433097K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking ScrewPHX2017-03-06
288151759012741K160484Optetrak Advanced PatellaJWH2016-03-18
288152034490278K153776Optetrak One Logic Femoral ComponentsMBH2016-03-10
288151877297455K153649Exactech® Novation® Element Press-fit Femoral StemMEH2016-08-31
288151285620742K153595Optetrak Logic Metaphyseal ConesJWH2016-03-25
288151231030455K153340Epic Extremity Plate SystemHRS2016-02-09
288151959358787K153333Epic Extremity Cannulated Screw SystemHWC2016-01-19
288151896443133K152217Exactech Vantage Total Ankle SystemHSN2016-03-10
288151173231098K152170Exactech Optetrak Logic Enhanced AssemblyJWH2015-09-03
288151769274942K150890Exactech Optetrak Logic CCJWH2015-05-29
288151187881270K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenospherePHX2015-05-14
288151948951833K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedMAX2015-05-11
288151264499853K150130Ascendant TM Cervical Spacer SystemODP2015-05-28
288151099411382K150066Exactech Alteon Monobloc Revision StemLZO2015-07-20
288151795235250K143659Equinoxe Mega ProsthesisKWT2015-04-09
288151633397924K141960Exactech® Novation® Crown Cup®LPH2015-09-03
288151754132673K141821ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSETLZO2014-08-28
288151572993693K141797ALTEON 6.5MM BONE SCREWSLPH2014-07-29
288151777658447K141129EXACTECH CERVICAL SPACER SYSTEMODP2014-08-15
288151459363545K140674EXACTECH TAPERED WEDGE FEMORAL STEMLZO2014-06-30
288152025082225K140302OPTETRAK LOGIC POROUS FEMORAL COMPONENTSMBH2014-07-30
288151052097591K140063EQUINOXE EXTRA SHORT HUMERAL HEADKWS2014-02-11
288151852405903K132582EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEMOVE2014-02-12
288151339426388K132161OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTSJWH2013-10-11
288151462389747K131575EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHTPHX2013-07-03
288151237147667K131298EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEMHSD2013-11-26
288151168125691K130434OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTICMAX2013-05-01
288151314743859K123687OPTETRAK LOGIC POROUS FEMORAL COMPONENTJWH2013-03-20
288151591301323K123607OCTANE ELEVATE SPINAL IMPLANT SYSTEMMAX2014-04-25
288151099807416K123342OPTETRAK LOGIC CRC TIBIAL INSERTJWH2013-01-10
288151379367802K122798INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELLLPH2012-10-11
288151997646990K121989OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,MQV2012-11-27
288151506745362K121684NOVATION LPI PRIME FEMORAL STEMLPH2012-10-01
288151298809791K121392NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREELZO2013-01-16
288151152229222K121307OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZJWH2012-05-31
288151312251957K121220EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHTKWS2012-11-20
288151349029866K121067EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATEPHX2012-12-06
288151251824825K113609NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5LPH2012-01-04
288151654477502K113320NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12MEH2012-03-16
288151441881427K113309EXACTECH EQUINOXE CAGE GLENOIDSKWS2011-12-08
288151057961994K111400OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENTJWH2011-07-28
288151983621111K111379EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHTKWS2011-06-08
288152012499533K110708EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...PHX2011-04-01
288151647878928K110706EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEADKWT2011-05-17
288151058992620K110547OPTERTRAK LOGIC PSC TIBIAL INSERTJWH2011-04-14
288151453820540K103699EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCCNUN2011-08-12
288151180571051K103655OCTANE-C INTERBODY FUSION DEVICE SYSTEMODP2011-06-30
288151297245801K103419EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TMKWS2010-12-13
288151759312966K103012EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADSLZO2010-11-10
288151059012912K102975NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLELPH2010-11-05
288151258593332K102951EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)PHX2010-11-04
288151486724017K102487NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20LZO2010-11-08
288151586062783K101981OPTETRAK LOGIC COMBINATION TIBIAL TRAYJWH2010-08-02
288152011272907K101909EXACTECH EQUINOXE, PLATFORM FRACTURE STEMPHX2010-08-02
288151449466522K101761EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13LPH2010-09-21

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
JWH322023-07-17
LZO202023-05-19
PHX192024-07-18
LPH192019-03-13
JDI122005-06-21
MEH82025-03-10
KWS82022-03-04
HRS72025-06-26
MBH52024-10-03
HSN42023-10-12
MAX42015-05-11
HSD42013-11-26
HWC32017-02-28
KWT32017-02-27
ODP32015-05-28
MBP32007-06-07
KWY32001-12-05
PKC22020-04-29
MQV22012-11-27
LWJ22009-04-21
KWZ22007-07-19
OQI12018-03-12
JDR12017-05-16
OVE12014-02-12
NUN12011-08-12
MRA12007-07-05
MQP12007-04-06
MNH12006-02-13
HRY12004-10-01
JDG11996-08-08
HWE11996-04-23
KWL11996-03-27
JDZ11994-04-29
HTZ11994-04-15
JDL11989-11-17

PMA

PMN

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