DEPUY ORTHOPAEDICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12196551219655DEPUY ORTHOPAEDICS, INC.1N2026-01-01325 PARAMOUNT DR. RAYNHAM MA US 02767
18189101818910DEPUY ORTHOPAEDICS, INC.1N2026-01-01700 ORTHOPAEDIC DR. WARSAW IN US 46582

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10603295552680ATTUNE - ATTUNE MAKE TO ORDER ROTATING TIBIAL STYLUS+1(800)255-2500xx@xx.xx
10603295553588ATTUNE - ATTUNE MAKE TO ORDER SOLID SPACER BLOCK SIZE 6mm+1(800)255-2500xx@xx.xx
10603295553595ATTUNE - ATTUNE MAKE TO ORDER SOLID SPACER BLOCK SIZE 8mm+1(800)255-2500xx@xx.xx
10603295553601ATTUNE - ATTUNE MAKE TO ORDER SOLID SPACER BLOCK SIZE 10mm+1(800)255-2500xx@xx.xx
10603295553618ATTUNE - ATTUNE MAKE TO ORDER SOLID SPACER BLOCK SIZE 12mm+1(800)255-2500xx@xx.xx
10603295555001ATTUNE - ATTUNE MAKE TO ORDER NON-CEMENTED PINNED TIBIAL BASE TRIAL SIZE 5+1(800)255-2500xx@xx.xx
10603295555018ATTUNE - ATTUNE MAKE TO ORDER NON-CEMENTED PINNED TIBIAL BASE TRIAL SIZE 6+1(800)255-2500xx@xx.xx
10603295555025ATTUNE - ATTUNE MAKE TO ORDER NON-CEMENTED PINNED TIBIAL BASE TRIAL SIZE 7+1(800)255-2500xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
38231948204226P960054S-ROM POLY-DIAL CONSTRAINED LINERKWZ1997-06-19
38231669817977P910016NEW JERSEY LCS(R) TOTAL KNEE SYSTEMNRA1992-10-30
38231494980439P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
38151494980439P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
38231552687517P090002PINNACLE COMPLETE ACETABULAR HIP SYSTEMOVO2011-06-13
38231056179924P070026CERAMAX CERAMIC HIP SYSTEMMRA2010-12-23
38231187822846K994415MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERSLPH2000-02-03
38231419374980K992656DEPUY TOTAL ELBOW SYSTEMJDC1999-11-05
38231013553564K992065GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEADKWS1999-07-12
38151659907198K991106P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAYJWH1999-06-09
38231659907198K991106P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAYJWH1999-06-09
38231733202644K984541GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEADKWT1999-01-14
38231765533450K984158P.F.C. MODULAR PLUS OFFSET TIBIAL TRAYJWH1999-01-28
38151765533450K984158P.F.C. MODULAR PLUS OFFSET TIBIAL TRAYJWH1999-01-28
38231505911296K983491DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINERLPH1998-12-02
38231436306779K983141CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESISJDB1998-11-06
38151436306779K983141CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESISJDB1998-11-06
38231548828976K983014SUMMIT ACETABULAR SYSTEMLPH1998-10-27
38151548828976K983014SUMMIT ACETABULAR SYSTEMLPH1998-10-27
38231619094274K982347DEPUY ACE TIMAX PILON PLATEHRS1998-08-31
38231830972751K982330DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANTFTM1998-09-25
38232028179372K981487DEPUY GLOBAL SHOULDER GLENOIDKWS1998-07-13
38231247773483K980513ARTICUL/EZE FEMORAL HEADSJDI1998-04-14
38231108390739K974740DEPUY TRI-LOCK HIP STEMLPH1998-03-18
38231088982226K972832PROVISION SURGICAL HELMET SYSTEMFYA1997-10-21
38231851889533K972643DEPUY AMK 3 PEG PATELLAJWH1998-01-21
38231980342022K972596DEPUY DURALOC ACETABULAR CUP SYSTEMLPH1997-11-12
38231833062145K971682J-FX CERCLAGE SYSTEMLRN1997-06-27
38231292646169K971652P.F.C. SIGMA INSET PATELLAJWH1997-07-16
38151292646169K971652P.F.C. SIGMA INSET PATELLAJWH1997-07-16
38151250351392K971189P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)JWH1997-07-17
38231250351392K971189P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)JWH1997-07-17
38231336397813K971070SCARF THREAD-HEAD (TM) HEAD SCREWHWC1997-07-09
38231554964077K97106834MM SCARF THREAD-HEAD(TM) SCREWHWC1997-07-09
38151820848018K970929DEPUY LOW PROFILE BONE SCREWHWC1997-06-09
38231820848018K970929DEPUY LOW PROFILE BONE SCREWHWC1997-06-09
38231739529414K970544DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESISKYJ1997-09-12
38231294030848K964795CEMENTED CALCAR REPLACEMENT FEMORAL STEMJDI1997-02-19
38231332548245K964114DEPUY OPTI-CON AND E-Z SHIELD SYSTEMSFXX1997-05-06
38231745144948K963309APEX HOLE ELIMINATOR PSLPH1996-11-12
38151012943645K963206S-ROM HIP SYSTEM - LOCKING PLUGJDI1996-10-17
38231012943645K963206S-ROM HIP SYSTEM - LOCKING PLUGJDI1996-10-17
38231249024695K963117P.F.C. CRUCIATE RETAING KNEE SYSTEMJWH1996-11-06
38151249024695K963117P.F.C. CRUCIATE RETAING KNEE SYSTEMJWH1996-11-06
38231447459534K962007PROTRUSION CAGESJDJ1996-08-01
38151447459534K962007PROTRUSION CAGESJDJ1996-08-01
38231120079518K961732KARMEH1997-07-08
38231238752491K961685P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)JWH1996-07-10
38151238752491K961685P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)JWH1996-07-10
38231353955474K961619DEPUY ENDURANCE CALCAR HIP PROSTHESISJDI1996-07-12
38231013891080K961239DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTRELFYA1996-09-17
38231993962203K961186DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEMLPH1996-09-17
38151861052911K955884COORDINATE REVISION KNEE SYSTEMJWH1996-03-13
38231861052911K955884COORDINATE REVISION KNEE SYSTEMJWH1996-03-13
38231316430613K955511ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUPLPH1996-02-26
38151310202430K955385JOHNSON & JOHNSON AUSTIN MOORE STEMKWL1996-01-30
38231560708369K954684DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERTJWH1996-01-26
38231009221526K954481P.F.C. UNI-COMPARTMENTAL KNEE SYSTEMHRY1996-10-10
38151009221526K954481P.F.C. UNI-COMPARTMENTAL KNEE SYSTEMHRY1996-10-10
38231121092894K953703DEPUY VISION SOLUTION HIP PROSTHESISLPH1996-02-01
38231087800004K953694DEPUY VISION AML HIP PROTHESISLPH1996-02-01
38151087800004K953694DEPUY VISION AML HIP PROTHESISLPH1996-02-01
38231791739443K953111CORAILLZO1996-12-27
38231103710533K952859ULTIMA CEMENTED LONG STEM FEMORAL COMPONENTJDI1996-01-31
38231611837498K952830DARWIN KNEE SYSTEM (TC3)JWH1996-01-18
38151611837498K952830DARWIN KNEE SYSTEM (TC3)JWH1996-01-18
38231440057532K952740DEPUY DURALOC 400 ACETABULAR CUPLPH1995-08-18
38231527978462K951674DEPUY DURALOC 100C ACETABULAR CUPLPH1995-05-11
38231204430595K951301DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEMLPH1995-04-18
38151316399517K951000ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEMLPH1995-04-14
38231316399517K951000ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEMLPH1995-04-14
38231359870674K950563ULTIMA AUGMENTED UHMWPE CUPKWL1995-06-07
38151941211282K950010DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATEDJWH1995-05-15
38231941211282K950010DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATEDJWH1995-05-15
38231577246738K944538GAS PLASMA STERILIZATIONHRY1995-09-26
38151577246738K944538GAS PLASMA STERILIZATIONHRY1995-09-26
38231437202582K944132P.F.C. TOTAL HIP SYSTEMKWY1995-01-06
38231491511371K943727BIOSTOP G BONE CEMENT RESTRICTORLZN1995-05-11
38231409362829K943696ALL POLYETHYLENE CEMENTED ACETABULAR CUPJDI1995-05-17
38151130397448K943462DARWIN KNEE SYSTEMJWH1994-12-21
38231130397448K943462DARWIN KNEE SYSTEMJWH1994-12-21
38231122409492K943299DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAYJWH1995-01-27
38231292077025K942370DEPUY CEMENTED HIP PROSTHESISJDI1994-11-10
38231021597044K941769KNEE PROTHESISJWH1995-02-01
38151021597044K941769KNEE PROTHESISJWH1995-02-01
38231383007550K940743UHMWPE COMPONENTS-CHANGE IN PACKAGINGKWY1995-09-18
38231790381930K936037S-ROM NOILES CRUCIATE RETAINING KNEEJWH1994-10-03
38151790381930K936037S-ROM NOILES CRUCIATE RETAINING KNEEJWH1994-10-03
38231569141849K935262P.F.C. TOTAL KNEE SYSTEM OVAL PATELLAJWH1994-06-03
38151569141849K935262P.F.C. TOTAL KNEE SYSTEM OVAL PATELLAJWH1994-06-03
38231776902652K934557CONTROL CABLE SYSTEMJDQ1994-02-25
38231885191532K933275P.F.C. CERAMIC HIP HEADLZO1994-09-28
38151143353850K931676S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUGJDL1994-05-18
38231143353850K931676S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUGJDL1994-05-18
38231491429671K931652ACE 6.5 MM BONE SCREWHWC1994-04-28
38231485492188K931641POROCOAT POROUS COATINGLPH1994-03-21
38231250058780K931189P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACETLZO1994-02-09
38231086532724K930712P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULARLZO1993-10-04
38231341581784K925025PRISM BONE CEMENT MIXING SYSTEMJDZ1994-01-05
38231636173501K924940FEMORAL & TIBIAL AUGMENT BLOCKJWH1993-03-09
38151636173501K924940FEMORAL & TIBIAL AUGMENT BLOCKJWH1993-03-09
38231985375614K924492POLY-DIAL INSERTSLPH1992-11-24
38151282716600K924340P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERTJWH1994-01-25
38231282716600K924340P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERTJWH1994-01-25
38231273088891K924115ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPSJDI1992-11-24
38231460409753K923807P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUSJWH1992-11-09
38151460409753K923807P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUSJWH1992-11-09
38152058457491K922824KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYMHSX1992-09-17
38232058457491K922824KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYMHSX1992-09-17
38231760235917K920802ALVINE TOTAL ANKLEHSN1992-12-17
38231432407521K920317S-ROM LF FEMORAL HEADJDI1992-03-19
38231055691387K920286DEPUY TOTAL HIP BALLS - ION IMPLANTATIONJDI1992-04-21
38231137599682K914702STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTSFXP1993-01-29
38231620467695K914694STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAUJCX1992-01-16
38231491683082K914077REPEL(TM) LITE CUT RESISTANT GLOVE LINERSLYU1991-12-02
38231755568916K914000GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPEKWT1991-12-04
38231194996645K912713S-ROM ZT HA PROXIMAL FEMORAL SLEEVEMEH1991-12-30
38231047714914K910992AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPEJWH1992-08-10
38231104347772K910941LIFELINER SURGICAL GLOVEFYE1991-05-09
38231181400812K910940ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAYJWH1991-09-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH802026-09-04
LPH552025-01-22
JDI342009-12-17
PHX212026-03-11
LZO192023-01-06
HRY122020-04-16
KRO102024-11-21
KWS102021-04-02
MBH82024-06-18
MEH82024-01-19
OIY72026-05-22
MQV72025-10-22
KWZ72024-04-04
MBF72023-11-13
HAW62007-05-23
HWC61997-07-09
HSB61988-12-01
OLO52026-06-25
KWL52026-05-15
HSN42012-10-31
HSD42008-12-18
FTM42007-09-04
NPJ42007-06-26
PKC32024-12-23
LLZ32023-08-22
KYJ32009-02-09
JDC32006-04-14
KWT31999-01-14
FYA31997-10-21
KWY31995-09-18
LYU31991-12-02
FMF22025-06-24
KWA22008-12-04
LWJ22003-02-05
JDB21998-11-06
JDJ21996-08-01
JDL21994-05-18
HSX21992-09-17
HTN21991-07-24
JEC21990-01-11

PMA#

109 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next