FDA.reportPublic FDA data

Exactech Sarasota

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30086582043008658204Exactech Sarasota1N2026-01-017455 16th Street East Suite 105 Sarasota FL US 34243
30143997563014399756Exactech Sarasota Molding1N2020-04-251189 Tallevast Road Sarasota FL US 34243

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1162941468460052K954208OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLYJWH1996-02-26
1162941308219261K933610EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTSJWH1995-01-17
2169991308219261K933610EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTSJWH1995-01-17
2169991661664803K932776CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTSJWH1994-10-20
1162941661664803K932776CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTSJWH1994-10-20
2169991971748515K932690EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SYJWH1995-02-09
1162941971748515K932690EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SYJWH1995-02-09
1162941042344441K233482Equinoxe® Central Screw Baseplate SystemPHX2024-07-18
1162941546282390K191561Exactech Equinoxe Humeral Augmented TraysPHX2019-08-20
1162941233108151K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsMBH2018-11-26
2169991680917011K171045Exactech® Truliant™ Line ExtensionsJWH2017-04-28
1162941680917011K171045Exactech® Truliant™ Line ExtensionsJWH2017-04-28
1162941896443133K152217Exactech Vantage Total Ankle SystemHSN2016-03-10
2169991173231098K152170Exactech Optetrak Logic Enhanced AssemblyJWH2015-09-03
1162941173231098K152170Exactech Optetrak Logic Enhanced AssemblyJWH2015-09-03
1162941769274942K150890Exactech Optetrak Logic CCJWH2015-05-29
1162941795235250K143659Equinoxe Mega ProsthesisKWT2015-04-09
1162941572993693K141797ALTEON 6.5MM BONE SCREWSLPH2014-07-29
1162941339426388K132161OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTSJWH2013-10-11
2169991339426388K132161OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTSJWH2013-10-11
2169991099807416K123342OPTETRAK LOGIC CRC TIBIAL INSERTJWH2013-01-10
1162941099807416K123342OPTETRAK LOGIC CRC TIBIAL INSERTJWH2013-01-10
1162941152229222K121307OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZJWH2012-05-31
2169991152229222K121307OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZJWH2012-05-31
1162941349029866K121067EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATEPHX2012-12-06
1162941441881427K113309EXACTECH EQUINOXE CAGE GLENOIDSKWS2011-12-08
1162941057961994K111400OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENTJWH2011-07-28
2169991057961994K111400OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENTJWH2011-07-28
1162942012499533K110708EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...PHX2011-04-01
2169991058992620K110547OPTERTRAK LOGIC PSC TIBIAL INSERTJWH2011-04-14
1162941058992620K110547OPTERTRAK LOGIC PSC TIBIAL INSERTJWH2011-04-14
1162941297245801K103419EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TMKWS2010-12-13
1162941258593332K102951EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)PHX2010-11-04
1162941593231798K093978EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEMHRS2010-05-11
1162942057609746K093430EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.KWS2010-09-02
1162941235645282K093360OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5TJWH2010-01-11
2169991235645282K093360OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5TJWH2010-01-11
1162941606367659K082702EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAYPHX2008-10-10
1162941424627342K082022OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++JWH2008-09-02
2169991424627342K082022OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++JWH2008-09-02
1162941472181319K063569EQUINOXE REVERSE SHOULDER SYSTEMPHX2007-02-23
1162941749061603K042021EXACTECH EQUINOXE SHOULDER SYSTEMKWS2004-10-26
1162941846020456K040889EXACTECH OPTETRAK UNICONDYLAR KNEEHRY2004-10-01
1162941166948786K033883OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABIJWH2004-02-13
2169991166948786K033883OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABIJWH2004-02-13
1162941608661583K023186OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAYJWH2002-10-17
1162941367401858K011976OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)JWH2001-07-16
2169991367401858K011976OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)JWH2001-07-16
1162941860674126
1162941011831825
1162941812159299

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH312017-04-28
PHX72024-07-18
KWS42011-12-08
MBH12018-11-26
HSN12016-03-10
KWT12015-04-09
LPH12014-07-29
HRS12010-05-11
HRY12004-10-01

PMN#