FDA.reportPublic FDA data

Patrick McCullagh

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30063560433006356043Patrick McCullagh1N2026-01-01700 Orthopaedic Drive Warsaw IN US 46582
30084900923008490092Patrick McCullagh1N2026-01-01700 Orthopaedic Drive Warsaw IN US 46582

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
38131494980439P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
38131056179924P070026CERAMAX CERAMIC HIP SYSTEMMRA2010-12-23
38131013553564K992065GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEADKWS1999-07-12
38131733202644K984541GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEADKWT1999-01-14
38131548828976K983014SUMMIT ACETABULAR SYSTEMLPH1998-10-27
38131537633783K982918DEPUY C-STEM SYSTEMJDI1998-10-05
38131886117902K980801J-FX BIPOLAR HEADKWY1998-05-29
38131247773483K980513ARTICUL/EZE FEMORAL HEADSJDI1998-04-14
38131980342022K972596DEPUY DURALOC ACETABULAR CUP SYSTEMLPH1997-11-12
38131250351392K971189P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)JWH1997-07-17
38131745144948K963309APEX HOLE ELIMINATOR PSLPH1996-11-12
38131238752491K961685P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)JWH1996-07-10
38131993962203K961186DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEMLPH1996-09-17
38131611837498K952830DARWIN KNEE SYSTEM (TC3)JWH1996-01-18
38131440057532K952740DEPUY DURALOC 400 ACETABULAR CUPLPH1995-08-18
38131204430595K951301DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEMLPH1995-04-18
38131941211282K950010DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATEDJWH1995-05-15
38131130397448K943462DARWIN KNEE SYSTEMJWH1994-12-21
38131383007550K940743UHMWPE COMPONENTS-CHANGE IN PACKAGINGKWY1995-09-18
38132065211506K903084MODULAR CATHCART FRACTURE SYSTEMLZY1990-10-03
38131413498218K900891MODIFIED AML + ACETABULAR CUP PROSTHESISJDI1990-03-12
38131367800818K900832MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.JDI1990-05-04
38131788653275K884796P.F.C.(TM) MODULAR KNEE SYSTEMJWH1989-03-29
38131727136498K883460FOCUS TOTAL HIP SYSTEMJDI1988-10-11
38131526157052K882234JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESISJWH1988-10-20
38131134863612K871867ELITE MODULAR HIP SYSTEMJDI1988-04-08
38131203479195K851422S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIPJDI1985-09-18
38131532586721K843909TITANIUM HIP 1019JDI1984-11-15
38131970820840K830927KNEE PROSTHESIS-TIBIAL COMPONENTJWH1983-07-19
38131519595907K812672SELF-CENTERING HIPKWY1981-10-08
38131727111246K802627ORTRON 90* HIP PROSTHESISJDI1980-12-16
38131836558053K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR ConditionalMEH2024-01-19
38131467145665K231526CORAIL Cemented Femoral StemKWY2023-12-19
38131024296391K220216C-Stem AMT LE ProsthesisJDI2022-07-22
38131643450737K212710GLOBAL UNITE™ Platform Shoulder SystemPHX2021-09-15
38131896324264K212683GLOBAL ICON Stemless Shoulder SystemPKC2022-01-19
38131209254635K211657EMPHASYS Femoral StemsLZO2021-08-05
38132036531261K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertJWH2021-08-25
38131284944172K202472ACTIS Duofix Hip ProsthesisLPH2020-10-21
38131928500572K202098GLOBAL UNITE™ Platform Shoulder SystemPHX2020-11-25
38131148685700K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemNKB2020-04-24
38131861367845K183077Delta Xtend Reverse Shoulder SystemPHX2019-05-17
38132050340121K170806ATTUNE Cemented Tibial Base, Fixed BearingJWH2017-06-15
38131409076165K170748GLOBAL UNITE Platform Shoulder SystemPHX2018-01-11
38131147492042K170339Summit Hip SystemLZO2018-04-26
38131886494978K160907DePuy Actis DuoFix Hip ProsthesisMEH2016-07-19
38131293182474K160904Expedium Spine System, VIPER and VIPER 2 SystemsNKB2016-07-01
38131504487111K160700ATTUNE Revision Knee SystemJWH2016-06-10
38131309884721K150862DePuy Actis Duofox Hip ProsthesisMEH2015-09-25
38131955256293K142460EXPEDIUM Spine System/Synapse SystemKWP2014-10-01
38131402058729K120599DEPUY M-SPEC 36MM FEMORAL HEADSLPH2013-04-30
38131234894133K120174DEPUT DELTA XTEND REVERSE SHOULDERPHX2012-06-11
38131057059364K111433DEPUY STTUNE (TM) PS KNEE SYSTEMOIY2011-08-30
38131643823601K111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMNKB2012-06-14
38131610533340K101433DEPUY ATTUNE KNEE SYSTEMOIY2010-12-10
38131818668797K082500DEPUY SIGMA CR-F FEMORAL COMPONENTJWH2008-11-18
38131914445203K082239DEPUY C-STEM AMTJDI2008-08-29
38131364167462K081620MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEMKWS2008-06-30
38131225621081K042959DEPUY C-STEM AMT HIP PROSTHESISJDI2004-12-22
38131543773774K040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062LPH2004-05-28
38131807273243K040166DEPUY SIGMA XLK TIBIAL INSERTSJWH2004-02-23
38131570326940K033901MERLIN SPINE SYSTEMNKB2004-03-31
38131798321958K033272DEPUY SIGMA TIBIAL INSERTSJWH2004-02-05
38131345018264K032151DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYSJWH2003-09-26
38131446333858K030122DEPUY SUMMIT BASIC PRESS-FIT HIP STEMLWJ2003-02-05
38132043502462K023453DEPUY SUMMIT FX CEMENTED HIP PROSTHESISJDI2002-11-13
38131017590694K013352SUMMIT CEMENTED HIP PROSTHESISJDI2001-12-17
38131527969190K003421DEPUY C-STEM SYSTEMJDI2000-12-01
38131760646368K000575GLOBAL ADVANTAGE EXTENDED HUMERAL HEADKWS2000-03-10
1195011637854877
38131111573509
38131312089002
38131358651161
38131400898936
38131722997311

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JDI152022-07-22
JWH152021-08-25
LPH92020-10-21
PHX52021-09-15
KWY42023-12-19
NKB42020-04-24
MEH32024-01-19
KWS32008-06-30
LZO22021-08-05
OIY22011-08-30
PKC12022-01-19
KWP12014-10-01
MRA12010-12-23
LWJ12003-02-05
KWT11999-01-14
LZY11990-10-03
NJL11985-04-12