FDA.reportPublic FDA data

Exactech Sarasota Molding

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
2169991308219261K933610EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTSJWH1995-01-17
2169991661664803K932776CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTSJWH1994-10-20
2169991971748515K932690EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SYJWH1995-02-09
2169991680917011K171045Exactech® Truliant™ Line ExtensionsJWH2017-04-28
2169991173231098K152170Exactech Optetrak Logic Enhanced AssemblyJWH2015-09-03
2169991339426388K132161OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTSJWH2013-10-11
2169991099807416K123342OPTETRAK LOGIC CRC TIBIAL INSERTJWH2013-01-10
2169991152229222K121307OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZJWH2012-05-31
2169991057961994K111400OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENTJWH2011-07-28
2169991058992620K110547OPTERTRAK LOGIC PSC TIBIAL INSERTJWH2011-04-14
2169991235645282K093360OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5TJWH2010-01-11
2169991424627342K082022OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++JWH2008-09-02
2169991166948786K033883OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABIJWH2004-02-13
2169991367401858K011976OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)JWH2001-07-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH142017-04-28