FDA.reportPublic FDA data

Patrick McCullagh

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96109213002806724Patrick McCullagh1N2026-01-01700 Orthopaedic Drive Warsaw IN US 46582
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
38251557871379P960001DEPUY 1 BONE CEMENTLOD1997-02-11
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
38251491511371K943727BIOSTOP G BONE CEMENT RESTRICTORLZN1995-05-11
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
38251035581259K873689CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIALGXP1987-10-26
38251191188700K873688ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIALJXH1987-10-26
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
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
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
38251129025046K141385DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)HBW2015-03-27
38131402058729K120599DEPUY M-SPEC 36MM FEMORAL HEADSLPH2013-04-30
38251039529312K112907CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20GNDN2011-12-22
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
38251335932668K081163SMARTSET GMV GENTAMICIN BONE CEMENTMBB2008-05-14
38251555432722K081155SMARTSET MV BONE CEMENTLOD2008-05-14
38251967471077K073115ORTHOMESHHRS2008-07-15
38251175367255K071927MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENTNDN2007-11-21
38251118152687K071791MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280GXP2007-07-30
38251591284493K071776ANEUROPLASTIC, MODEL 43-1290JXH2007-07-26
38251096742506K062789SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEMJEY2007-02-27
38251921549294K061144DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENTMBB2006-06-08
38251169292206K053445SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENTLOD2006-01-06
38251216939045K053022SYNTHES (USA) CHRONOS-BETA-TCPLYC2006-01-23
38252045365682K053003DEPUY CMW 1, 2 AND 3 BONE CEMENTSLOD2005-11-22
38251913446617K053002DEPUY CMW 1 GENTAMICIN BONE CEMENTMBB2005-11-22
38251088108237K043406VERTEBROPLASTIC RADIOPAQUE BONE CEMENTNDN2005-07-15
38131225621081K042959DEPUY C-STEM AMT HIP PROSTHESISJDI2004-12-22
38251946152407K042591SMARTMIX PRE-FILLED MIXING SYSTEMKIH2004-10-22
38251852583203K041656MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENTLOD2004-07-01
38251145555075K041611SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMPGXR2004-09-08
38251485812550K041350SYNTHES (USA) CHRONOSGXP2004-07-08
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
38251341079843K033563SMARTSET GHV GENTAMICIN BONE CEMENTLOD2004-02-05
38251885347714K033382SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENTLOD2004-02-05
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
38251766675514K030069SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEMJEY2003-04-08
38132043502462K023453DEPUY SUMMIT FX CEMENTED HIP PROSTHESISJDI2002-11-13
38251981832239K023103DEPUY 1 GENTAMICIN BONE CEMENTLOD2003-09-29
38251544046619K023012SMARTSET HV BONE CEMENTLOD2003-02-13
38251782731637K021499CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENTLOD2002-07-24
38251555708706K014053CONDUIT TCP GRANULESMQV2002-03-08
38131017590694K013352SUMMIT CEMENTED HIP PROSTHESISJDI2001-12-17
38131527969190K003421DEPUY C-STEM SYSTEMJDI2000-12-01
38131760646368K000575GLOBAL ADVANTAGE EXTENDED HUMERAL HEADKWS2000-03-10
1195011637854877
38131111573509
38251190570014
38131312089002
38131358651161
38131400898936
38251424947010
38131722997311
38251756675271

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
LOD92008-05-14
KWY42023-12-19
NKB42020-04-24
MEH32024-01-19
PHX32021-09-15
NDN32011-12-22
MBB32008-05-14
GXP32007-07-30
LZO22021-08-05
OIY22011-08-30
JXH22007-07-26
JEY22007-02-27
KWS22000-03-10
HBW12015-03-27
KWP12014-10-01
MRA12010-12-23
HRS12008-07-15
LYC12006-01-23
KIH12004-10-22
GXR12004-09-08
LWJ12003-02-05
MQV12002-03-08
KWT11999-01-14
LZN11995-05-11
LZY11990-10-03
NJL11985-04-12