FDA.reportPublic FDA data

DEPUY ORTHOPAEDICS, INC.

Matched from indexed company URL: DEPUY ORTHOPAEDICS

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
30044643253004464325DEPUY ORTHOPAEDICS1Y2026-01-0150 SCOTLAND BLVD. BRIDGEWATER MA US 02324

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
10603295015543DURALOC - Duraloc MARATHON ACETABULAR LINER 10 DEGREES Lip 32mm ID 54mm OD+1(800)255-2500xx@xx.xx
10603295015550DURALOC - Duraloc MARATHON ACETABULAR LINER 10 DEGREES Lip 32mm ID 56 or 68mm OD+1(800)255-2500xx@xx.xx
10603295015567DURALOC - Duraloc MARATHON ACETABULAR LINER 10 DEGREES Lip 32mm ID 58 or 70mm OD+1(800)255-2500xx@xx.xx
10603295015574DURALOC - Duraloc MARATHON ACETABULAR LINER 10 DEGREES Lip 32mm ID 60 or 72mm OD+1(800)255-2500xx@xx.xx
10603295015581DURALOC - Duraloc MARATHON ACETABULAR LINER 10 DEGREES Lip 32mm ID 62 or 74mm OD+1(800)255-2500xx@xx.xx
10603295015598DURALOC - Duraloc MARATHON ACETABULAR LINER 10 DEGREES Lip 32mm ID 64mm OD+1(800)255-2500xx@xx.xx
10603295015604DURALOC - Duraloc MARATHON ACETABULAR LINER 10 DEGREES Lip 32mm ID 66mm OD+1(800)255-2500xx@xx.xx
10603295155010NA - SKIN HOOK SET OF TWO+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
38121494980439P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
38151494980439P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
38231494980439P830055LCS(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
38121748058025K994121SMALL STATURE USSMNI2000-10-17
38121537792186K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMHTO2000-06-12
38122067011537K993314SYNTHES LIGHT GUIDEFQP1999-12-06
38121470593845K993099BREMER HALO SYSTEM TITANIUM SKULL PINJEC1999-12-15
38121793537118K992898THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEMGZT1999-10-21
38231419374980K992656DEPUY TOTAL ELBOW SYSTEMJDC1999-11-05
38121633313327K992616SDB CERCLAGE SYSTEMJDQ1999-10-27
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
38121908056498K984498SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEMKTT1999-02-18
38121792088776K984350VSP SYSTEMMNI1999-01-20
38151765533450K984158P.F.C. MODULAR PLUS OFFSET TIBIAL TRAYJWH1999-01-28
38231765533450K984158P.F.C. MODULAR PLUS OFFSET TIBIAL TRAYJWH1999-01-28
38121819331806K983766SYNTHES SYNMESHEZX1998-12-18
38231505911296K983491DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINERLPH1998-12-02
38151436306779K983141CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESISJDB1998-11-06
38231436306779K983141CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESISJDB1998-11-06
38151548828976K983014SUMMIT ACETABULAR SYSTEMLPH1998-10-27
38231548828976K983014SUMMIT ACETABULAR SYSTEMLPH1998-10-27
38121015244397K982483DEPUY MOTECH PEAK FIXATION SYSTEMHRS1998-09-14
38121512153758K982443DOC VENTRAL CERVICAL STABILIZATION SYSTEMKWQ1998-07-29
38231619094274K982347DEPUY ACE TIMAX PILON PLATEHRS1998-08-31
38231830972751K982330DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANTFTM1998-09-25
38121892558015K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
38232028179372K981487DEPUY GLOBAL SHOULDER GLENOIDKWS1998-07-13
38121647515773K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
38121870159445K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
38231247773483K980513ARTICUL/EZE FEMORAL HEADSJDI1998-04-14
38121589810041K980485ISOLA SPINAL SYSTEMMNI1998-10-21
38121288525231K980368DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEMHRS1998-04-14
38121782930331K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
38231108390739K974740DEPUY TRI-LOCK HIP STEMLPH1998-03-18
38121980781251K974554SYNTHES RESORBABLE FIXATION SYSTEMJEY1998-02-24
38231088982226K972832PROVISION SURGICAL HELMET SYSTEMFYA1997-10-21
38231851889533K972643DEPUY AMK 3 PEG PATELLAJWH1998-01-21
38231980342022K972596DEPUY DURALOC ACETABULAR CUP SYSTEMLPH1997-11-12
38121027216246K971987SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORJEY1997-06-24
38121833062145K971682J-FX CERCLAGE SYSTEMLRN1997-06-27
38231833062145K971682J-FX CERCLAGE SYSTEMLRN1997-06-27
38151292646169K971652P.F.C. SIGMA INSET PATELLAJWH1997-07-16
38231292646169K971652P.F.C. SIGMA INSET PATELLAJWH1997-07-16
38121571015956K971544SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)HWE1997-05-28
38122001781747K971248KANEDA SR ANTERIOR SPINAL SYSTEMKWQ1997-06-11
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
38121593335067K963618SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)LXT1996-11-12
38231745144948K963309APEX HOLE ELIMINATOR PSLPH1996-11-12
38151012943645K963206S-ROM HIP SYSTEM - LOCKING PLUGJDI1996-10-17
38231012943645K963206S-ROM HIP SYSTEM - LOCKING PLUGJDI1996-10-17
38121699347753K963172SYNTHES STERILE 4.5 MM CANNULATED SCREWSHWC1996-11-08
38151249024695K963117P.F.C. CRUCIATE RETAING KNEE SYSTEMJWH1996-11-06
38231249024695K963117P.F.C. CRUCIATE RETAING KNEE SYSTEMJWH1996-11-06
38121797709326K962913SYNTHES STERILE DRILL BITSHWE1996-11-14
38151447459534K962007PROTRUSION CAGESJDJ1996-08-01
38231447459534K962007PROTRUSION CAGESJDJ1996-08-01
38231120079518K961732KARMEH1997-07-08
38151238752491K961685P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)JWH1996-07-10
38231238752491K961685P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)JWH1996-07-10
38231353955474K961619DEPUY ENDURANCE CALCAR HIP PROSTHESISJDI1996-07-12
38121144975287K961350SYNTHES MINI EXTERNAL FIXATORKTT1996-06-28
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
38121508788215K955348TITANIUM MOSS MIAMI SPINAL SYSTEMKWP1996-02-16
38231560708369K954684DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERTJWH1996-01-26
38151009221526K954481P.F.C. UNI-COMPARTMENTAL KNEE SYSTEMHRY1996-10-10
38231009221526K954481P.F.C. UNI-COMPARTMENTAL KNEE SYSTEMHRY1996-10-10
38121134096847K954069ACE CERVICAL TRACTION HALOZS, TONGS & PINSHAX1995-10-12
38231121092894K953703DEPUY VISION SOLUTION HIP PROSTHESISLPH1996-02-01
38151087800004K953694DEPUY VISION AML HIP PROTHESISLPH1996-02-01
38231087800004K953694DEPUY VISION AML HIP PROTHESISLPH1996-02-01
38231791739443K953111CORAILLZO1996-12-27
38231103710533K952859ULTIMA CEMENTED LONG STEM FEMORAL COMPONENTJDI1996-01-31
38151611837498K952830DARWIN KNEE SYSTEM (TC3)JWH1996-01-18
38231611837498K952830DARWIN 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
38121789240884K950384SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATORLXT1995-05-22
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
38151577246738K944538GAS PLASMA STERILIZATIONHRY1995-09-26
38231577246738K944538GAS PLASMA STERILIZATIONHRY1995-09-26
38231437202582K944132P.F.C. TOTAL HIP SYSTEMKWY1995-01-06
38121710322241K943819ISOLA ANTERIOR SYSTEMKWQ1995-02-09
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
38151021597044K941769KNEE PROTHESISJWH1995-02-01
38231021597044K941769KNEE PROTHESISJWH1995-02-01
38231383007550K940743UHMWPE COMPONENTS-CHANGE IN PACKAGINGKWY1995-09-18
38151790381930K936037S-ROM NOILES CRUCIATE RETAINING KNEEJWH1994-10-03
38231790381930K936037S-ROM NOILES CRUCIATE RETAINING KNEEJWH1994-10-03
38151569141849K935262P.F.C. TOTAL KNEE SYSTEM OVAL PATELLAJWH1994-06-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH782021-08-25
LPH552025-01-22
JDI342009-12-17
PHX212026-03-11
KTT202016-11-10
LZO192023-01-06
NKB172017-08-31
KWQ162013-09-06
HRS152024-07-26
HSB122020-09-23
HRY122020-04-16
MQV112025-10-22
HWC112018-11-21
KRO102024-11-21
KWS92014-04-03
MNI92007-06-08
MBH82024-06-18
OLO82024-06-14
MEH82024-01-19
KWZ72024-04-04
MBF72023-11-13
KWP72014-09-25
HAW72012-12-17
OIY62024-11-01
MAX62014-06-13
FTM62009-10-22
MQP62008-01-25
HWE62005-01-05
HTO52011-08-10
JEY52007-02-27
HTN42017-12-14
HSN42012-10-31
HSD42008-12-18
JEC42007-08-24
NPJ42007-06-26
LXT42005-04-11
KWL41996-01-30
FMF32025-06-24
KCT32025-03-28
PKC32024-12-23

PMA#

CERAMAX Ceramic Total Hip System

2022-12-08

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS103 Date Received11/28/2022 Decision Date12/08/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

CERAMAX® Ceramic Total Hip System

2022-10-04

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS102 Date Received09/07/2022 Decision Date10/04/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

CERAMAX® Ceramic Total Hip System

2022-08-26

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS101 Date Received07/28/2022 Decision Date08/26/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

CERAMAX® Ceramic Total Hip System

2022-07-12

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS100 Date Received07/01/2022 Decision Date07/12/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

Ceramax Ceramic Total Hip System

2022-06-07

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS098 Date Received05/09/2022 Decision Date06/07/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

CERAMAX® Ceramic Total Hip System

2022-05-05

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS097 Date Received04/07/2022 Decision Date05/05/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason ...

CERAMAX Ceramic Total Hip System

2022-04-14

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS096 Date Received04/06/2022 Decision Date04/14/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

Ceramax® Ceramic Total Hip System

2022-03-22

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS094 Date Received02/22/2022 Decision Date03/22/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason ...

CERAMAX Total Hip System

2022-03-10

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS093 Date Received02/14/2022 Decision Date03/10/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

CERAMAX® Ceramic Total Hip System

2022-02-22

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS091 Date Received02/11/2022 Decision Date02/22/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

119 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next