FDA.reportPublic FDA data

ZIMMER PTE. LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30131760803013176080ZIMMER PTE. LTD.1N2026-01-01401 Commonwealth Drive #06-03 How Par Techno Centre Singapore South East SG 149598

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2126492036867809N17755ZIMMER(R) BONE CEMENTLOD1976-05-17
2126491546684450K994326ASCENT KNEE SYSTEMKWH2000-01-07
2126491473974384K994184PLR SPLINED REVISION STEMLZO2000-02-15
2126491479477712K994038MODULAR REACH HIPLPH1999-12-22
2126491889624329K993956TITANIUM PEDIATRIC FEMORAL NAILHSB1999-12-20
2126491344064367K993886EBI XFIX VISION FIXATION SYSTEMKTT1999-12-14
2126491060324026K993649EBI XFIX DFS WRISTFIX SYSTEMKTT1999-11-19
2126491820950957K993510MODIFIED BMP TROCHANTERIC PLATESHRS1999-11-16
2126491545522133K993438METAL ON METAL ACETABULAR SYSTEMKWA2000-05-18
2126491814367727K993259INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADSLPH2000-03-10
2126491269288386K993111ASCENT KNEE SYSTEMJWH1999-10-05
2126491093991422K992301REUNITE SCREWSHWC1999-09-01
2126492029295835K992119BIO-MODULAR SHOULDER SYSTEMKWS1999-09-13
2126491318788485K991990TRI-POLAR SYSTEMKWY1999-09-10
2126491142283966K991941EBI XFIX DFS RAIL SYSTEMKTT1999-08-19
2126491406099747K991807TITANIUM LOW PROFILE SCREWSLPH1999-07-08
2126491816661581K991806VHS SUPRACONDYLAR PLATE SYSTEMKTT1999-08-06
2126491367291059K991763LACTOSORB HAND SYSTEMHRS1999-07-30
2126491323858217K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
2126491636693907K991428ASCENT KNEE SYSTEMJWH1999-05-21
2126491355088889K991298BONE MULCH SCREW SYSTEMHWC1999-05-14
2126491633976488K990291LACTOSORB BONE PINHTY1999-03-23
2126492032594018K990135TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENELPH1999-07-12
2126491396097916K984390LACTOSORB PANELS AND FASTENERSHRS2000-08-07
2126491935627807K984296LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENTLPH1999-02-18
2126491364715020K984209STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PEDHWC1999-02-03
2126491863557780K984028THE NEW BIO-MOORE ENDO HEADSKWL1999-01-19
2126491434771267K983910ARTHRO-SURGIMAT-1500HRX1998-11-25
2126491048171554K983509INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERTLPH1999-02-03
2126491809786446K983265DEPUY ACE COMPOSITE LOCKING NUTHTN1998-10-26
2126491637879007K983153NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTSJWH1998-12-04
2126491875892932K982981NEW ZIMMER SHOULDER SYSTEMKWT1998-12-17
2126491422002397K982953TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLESHSB1998-10-21
2126492010297042K982903SULZER ORTHOPEDICS FLUTED STEMSJWH1998-10-21
2126491855523636K982869ASCENT SYSTEMJWH1998-09-22
2126491899195295K982545BMP CABLE SYSTEMJDQ1998-10-19
2126491532182618K982367REACH HIP COMPONENTLPH1998-08-24
2126491444883188K982095LACTOSORB MENISCAL REPAIR DEVICEMAI1999-01-27
2126491364105417K981967WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCREMBI1998-07-17
2126491751632964K981483EBI DFS JOINT FIXATOR, MODEL 02800KTT1998-07-08
2126491899860217K980711HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATINGLPH1998-11-12
2126491910972922K980665REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTSHRY1998-05-20
2126491678342092K980370BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATORKTT1998-04-14
2126491546693083K974781DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAILHSB1998-03-10
2126491421515306K974558SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEMJDI1998-03-04
2126491047181137K974316HYDROFERA FEMORAL WICKEFQ1998-02-13
2126491479025160K973775HARPOON SUTURE ANCHORSMBI1998-04-16
2126491003462873K973714VERSYS HIP SYSTEM BEADED HIP PROSTHESISLPH1997-12-24
2126492024041666K973681NATURAL-HIP COCR OFFSET STEMLZO1997-12-19
2126491145630697K973675NATURAL-HIP POROUS STEM WITH OFFSETLPH1997-12-19
2126491593909437K973412NATURAL-KNEE II CONSTRAINED KNEE SYSTEMJWH1997-12-08
2126491829469875K973357COONRAD/MORREY TOTAL ELBOW, NEW HINGE PINJDC1998-03-02
2126491544720345K973124APR POROUS HA HIP SYSTEMLPH1997-11-03
2126491877996180K972774GAS PLASMA STERILIZATIONJWH1999-05-05
2126491912884449K972501APOLLO REVISION/CONSTRAINED KNEE SYSTEMJWH1997-10-01
2126491473730300K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAILHSB1997-08-26
2126491429422554K971938REPICCI II UNICONDYLAR KNEEHRY1997-08-25
2126492064415217K971890RECOVERY PROTRUSIO CAGEJDI1997-08-07
2126491357748386K971824REACH FEMORAL HIP COMPONENTLPH1997-12-04
2126491783821861K971770APOLLO KNEE FEMORAL SPACERSJWH1997-07-31
2126491381448587K971715SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTSKWS1997-08-07
2126491636569207K970705INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLESLPH1997-05-22
2126491604148572K970300NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTILPH1997-07-03
2126491657262262K970290EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEMKTT1997-04-01
2126492042225244K970202DEPUY ACE AIM TITANIUM TIBIAL NAILHSB1997-03-21
2126491370602752K970166NATURAL-HIP SYSTEM COCR REVISION STEMLZO1997-04-08
2126491523099493K965098INTRAMEDULLARY NAIL SYSTEMHSB1997-02-28
2126491371117650K964970BIOMET BONE SCREWHWC1997-04-03
2126491891571473K964880VARI-ANGLE HIP SCREW (VHS) SYSTEMKTT1997-10-16
2126491768411482K964769VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESISLPH1997-02-13
2126491502876686K963266NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLAREDLPH1996-10-15
2126491528138419K963155INTERMOORE FRACTURE HIP STEM (MODIFY)LWJ1996-10-01
2126491642748899K963148NEXGEN COMPLETE KNEE SOLUTIONJWH1997-02-13
2126491748236162K963109HERITAGE HIP SYSTEMJDI1997-01-09
2126491512471738K962561SUPRACONDYLAR INTRAMEDULLARY NAILHSB1996-09-25
2126491836349996K962468HEDROCEL ACETABULAR RESTRICTORJDI1997-02-03
2126491226896583K962289SELECT SHOULDER COCR HUMERAL STEM COMPONENTHSD1996-08-29
2126491863451595K962238SELECT SHOULDER KEELED ALL-POLY GLENOIDSKWT1996-08-09
2126491476211118K962236SCARF THREAD-HEAD SCREWHWC1996-09-20
2126491885407476K962233TWIST-OFF SCREWHWC1996-10-03
2126491201873783K962224SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTSKWS1996-08-28
2126491301891843K961589APR FULLY TEXTURED HIP STEMLZO1996-07-09
2126492058231790K961571COCR BI-ANGULAR HUMERAL COMPONENTKWT1996-08-05
2126491982870685K961378DELTA HIP PROSTHESISLWJ1996-10-08
2126491614471356K961260KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAYHSD1997-04-02
2126491497122080K960658COLLARLESS POLISHED TAPER HIP PROSTHESISJDI1996-07-16
2126491005770470K960626MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)JDI1996-04-18
2126491287082463K960535APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLAJWH1996-04-23
2126491978111778K960363BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143MJT1997-02-18
2126491332644007K960279NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACESJWH1996-04-26
2126491200692299K960278COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENTJDI1996-07-25
2126491918003093K960258NATURAL HIP SYSTEMJDI1996-07-12
2126491364509701K955778NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEMHRY1996-03-08
2126491410841838K955473GAMMA SYSTEMJDI1996-02-16
2126491260075767K955472ACE HUMERUS & RADIUS PLATESHRS1996-04-01
2126492053062569K955033RIM FLARE ACETABULAR COMPONENTLPH1996-01-31
2126491161448134K954854INTERMOORE FRACTURE HIP STEMLWJ1996-02-15
2126491455096509K954800APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)MEH1996-04-25
2126491821839162K954744ZCH ALPHA SYSTEMJDI1996-01-23
2126491469727280K954698TRILOGY ACETABULAR COMPONENT 7MM OFFSETLPH1996-01-17
2126491525931151K954443LACTOSORB SUTURE ANCHORJDR1996-01-31
2126491123875254K953925FINE GRAIN CAST COBALT CHROMIUM HIP STEMSLZO1996-01-31
2126491620532695K953490TRILOGY ACETABULAR SHELL & LINERS 36MMLPH1995-10-20
2126491031353933K953337BETA HIP PROSTHESISLPH1996-01-22
2126491985340864K951658LACTOSORB POP RIVETJDR1995-07-25
2126491437867239K951357EBI SMALL EXTERNAL FIXATOR (S/E/F/)KTT1995-06-21
2126491899361896K950618ACE SUPRACONDYLAR PLATEHRS1995-05-10
2126491368471372K950312ALPHA SYSTEMJDI1995-05-17
2126491636147178K946150CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)JWH1995-07-11
2126491120966117K945765HIGH TEMPERATURE CAUTERYGEI1995-01-30
2126491922078471K945028FINN KNEE SYSTEMKRO1996-02-14
2126491185530511K943806HARPOON SUTURE ANCHORSHWC1995-07-03
2126491416506065K943025FREEMAN/SAMUELSON TOTAL KNEE SYSTEMJWH1996-03-13
2126491218483158K942479INTEGRAL CO-CR FEMORAL COMPONENTJDG1994-09-20
2126491249611254K942263MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEMHSX1995-07-11
2126491655778489K942028RX90 FEMORAL COMPONENTJDG1994-09-19
2126491641772981K941941BONE MULCH SCREWHWC1995-02-02
2126491975253785K941617APR ACETABULAR INSERTJDI1994-10-06
2126491007838461K936159NATURAL-KNEE II SYSTEMJWH1995-05-22
2126492024360694K936045ACE UNILATERAL FIXATOR IIJEC1994-02-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LPH602015-02-10
JWH592017-07-28
JDI512007-05-04
KTT412015-05-01
HRS382014-10-22
HWC352009-05-06
HSB272014-10-22
KRO172013-10-24
KWA142010-12-07
LZO142008-09-26
HRY112007-02-02
MBH102008-04-21
KWT102005-04-11
MBI92015-09-04
PHX82013-10-08
KWS82007-06-29
HTY82004-07-30
JDC72009-03-25
LXT72009-03-11
KWY72008-10-31
HSD62005-09-29
MEH62002-05-31
HRX52008-09-09
KWZ52008-01-07
JDR52006-07-25
HSX52004-01-16
LWJ52000-11-15
JDW42011-02-17
LOD32009-10-27
JDL32008-08-07
KXA32007-06-29
KRR32007-06-07
GAT32007-02-09
MBF32006-06-12
HAW32006-03-21
KWL31999-01-19
JDG31994-09-20
JEC31994-02-22
JDQ22015-07-01
HTN22009-09-11