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STELKAST COMPANY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25301911000307053STELKAST COMPANY1N2020-04-25200 HIDDEN VALLEY RD. Canonsburg PA US 15317

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
470811847934304K99162226 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINERJDI1999-07-14
470811858997626K981451ARGOMEDICAL BIPOLAR SYSTEMKWL1998-08-21
470811637482719K980276STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEMJWH1998-04-24
470811042417631K970490PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENTLZO1997-05-02
470811336739445K970194PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENTJDI1997-04-14
470811080600725K960908SRRS PRESSED FIT FEMORAL REVISION COMPONENTLWJ1996-08-08
470811256294385K96018022 MM COCR HEAD & POLYETHLENE LINERLPH1996-05-02
470811762027123K954466PROFORM POROUS BEADED FEMORAL STEMLPH1995-12-04
470811444207151K953268DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENTLWJ1996-01-17
470811338522794K953169STELKAST ALL POLYETHYLENE ACETABULAR CUPLZO1995-08-08
470811232457973K952461ENDO PROSTHESIS FEMORAL HEADJDI1995-06-30
470811502236753K951083PROFORM CEMENTED FEMORAL COMPONENTJDG1995-05-22
470811889613837K946371PROVIDENT HP SYSTEMJDI1995-04-05
470811947788478K935484PROVIDENT HIP SYSTEMLPH1994-06-06
470811853064650K934162PROFORM HA HIP SYSTEMJDO1994-03-09
470811088702561K934161PROFORM HIP SYSTEMJDO1994-03-10
470811772096809K190276Provident II Hip StemLPH2019-03-08
470811392194575K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertJWH2018-01-19
470811083043983K162222GENflex2 Total Knee SystemJWH2016-09-07
470811433036206K122883EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEMJWH2013-08-05
470811437735400K122773CROSS-OVER ACETABULAR SHELL & LINEROQG2012-10-09
470811125624831K094035EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MMOQG2011-03-24
470811295383439K081458PROVEN STEM EXTENDERJWH2008-06-06
470811310923979K063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERTJWH2007-01-18
470811582099003K051976PROVEN REVISION MODULAR TIBIAL TRAYJWH2005-10-17
470811325990001K032824STELKAST UNICONDYLAR KNEE SYSTEMHSX2003-11-13
470811238716091K032110PROCLASS PRESS FIT HIP STEMLWJ2003-09-22
470811437702987K031901PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERTJWH2003-10-10
470811559045052K030577PROVEN MODULAR TIBIAL TRAYJWH2003-03-25
470811107400250K021908PROVEN MODULAR POSTERIOR STABILIZED FEMORALJWH2002-07-09
470811831944929K010282LATERAL OFFSET PROTRACT PRESS FIT HIP STEMLPH2001-02-09
470811867465857K010241PROTRACT PRESS FIT HIP STEM-HA COATEDLPH2001-02-08
470812069691389K003447PROTRACT PRESS FIT HIP STEMLPH2000-12-15
470812058704556K002796MODIFICATION TO PROVIDENT HIP SYSTEMLWJ2000-09-28
470811373865220K002281STELKAST PROVEN KNEE SYSTEMJWH2000-08-17
470811653731599K001984PROGENY FORGED COCR CEMENTED FEMORAL COMPONENTJDG2000-09-27
470811411231135K001745MODIFICATION TO PROVIDENT HIP SYSTEMLWJ2000-07-27
470811819529205K000113PROVEN KNEE SYSTEMJWH2000-04-04
470811112014394
470811212060314
470811297660406
470811299866760
470811343804179
470811397283161
470811451227524
470811503351060
470811570885678
470811596581606
470811611624954
470811648123934
470811649804924
470812048736410

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH122018-01-19
LPH72019-03-08
LWJ52003-09-22
JDI41999-07-14
OQG22012-10-09
JDG22000-09-27
LZO21997-05-02
JDO21994-03-10
HSX12003-11-13
KWL11998-08-21

PMA#

PMN#

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