FDA.reportPublic FDA data

ZIMMER MANUFACTURING B.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
26489201000132037ZIMMER MANUFACTURING B.V.1N2027-01-01ROUTE 1, KM. 123.4, BLDG. 2 TURPEAUX INDUSTRIAL PARK MERCEDITA PR US 00715

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
38821321022132K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
38821415906026K990135TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENELPH1999-07-12
38821747797187K965098INTRAMEDULLARY NAIL SYSTEMHSB1997-02-28
38821671992285K963148NEXGEN COMPLETE KNEE SOLUTIONJWH1997-02-13
38821909152658K963109HERITAGE HIP SYSTEMJDI1997-01-09
38821744641988K962561SUPRACONDYLAR INTRAMEDULLARY NAILHSB1996-09-25
38821360804174K960658COLLARLESS POLISHED TAPER HIP PROSTHESISJDI1996-07-16
38821243785628K960279NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACESJWH1996-04-26
38821357134432K960278COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENTJDI1996-07-25
38821999825771K955473GAMMA SYSTEMJDI1996-02-16
38821462961650K954698TRILOGY ACETABULAR COMPONENT 7MM OFFSETLPH1996-01-17
38821918044608K954555VERSA-FX FEMORAL FIXATION SYSTEMKTT1996-01-26
38821674092034K953490TRILOGY ACETABULAR SHELL & LINERS 36MMLPH1995-10-20
38821245048353K953337BETA HIP PROSTHESISLPH1996-01-22
38821497095662K950312ALPHA SYSTEMJDI1995-05-17
38821283177322K934765TRILOGY ACETABULAR SYSTEMLPH1994-04-29
38821725557653K933785NEXT GENERATION KNEE SYSTEMJWH1995-01-30
38821827621916K913649MODULAR CALCAR REPLACEMENTJDI1991-11-13
38821137092669K901240ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTEDJDI1990-03-26
38821436064914K892800MG II POROUS TOTAL KNEE SYSTEMJWH1989-08-03
38821693841805K880155MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEEHSX1988-08-03
38821173605204K872379INSALL/BURSTEIN* II MODULAR TOTAL KNEEJWH1987-10-28
38822007656104K872019BI-ARTICULAR II HIP DEVICEKWY1987-07-21
38821645113493K853661MILLAR/GALANTE PRECOATED TOTAL KNEEJWH1985-12-09
38822031715431K840643HARRIS-GALANTE POROUS TOTAL HIP SYSJDI1984-04-17
38821835418951K833991BIPOLAR HIP DEVICEKWY1984-01-30
38821544876031K830196CORSTREN COMPRESSION TUBE & PLATEKTT1983-03-25
38821287430770K830121INSALL/BURSTEIN FIBER METAL CONDYLAR/KNEJWH1983-04-26
38821404676665K792022HERBERT BONE SCREWHWC1979-10-26
38821886155306K210842VerSys Cemented Revision/CalcarJDI2021-12-10
38821195811206K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IJDI2020-07-09
38821008853778K191735CPT Hip SystemJDI2020-03-20
38821448229089K191449ZCA All-Poly Acetabular CupsJDI2020-07-16
38821628558792K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadLPH2019-11-05
38822036333817K173057Zimmer Knee Joint Replacement Prostheses MR LabelingJWH2018-03-29
38821821016181K172524Zimmer Persona Personalized Knee SystemMBH2018-05-17
38821481469297K152841Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsHWC2015-11-24
38821841150053K151448Continuum and Trilogy Integrated Taper (IT) Acetabular SystemsLPH2015-08-13
38821406232866K150818Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation SystemKTT2015-05-01
38821415736639K150121Zimmer Periarticular Plating SystemHRS2015-02-23
38821854276562K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSHRS2015-03-04
38821630755810K143321ITST Intertrochanteric/Subtrochanteric Fixation SystemHSB2015-05-29
38821826726741K143165Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone ScrewHWC2015-03-31
38822043125480K143066Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and WashersHRS2014-11-28
38821439813294K142836Zimmer Plates and Screws (ZPS), Forte ScrewsHRS2014-11-12
38821514147437K142579Zimmer Periarticular Plating SystemHRS2014-10-22
38821576262419K142442MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEMHWC2014-10-03
38821956695140K142281ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEMHSB2014-10-22
38821300406670K141517ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATESHRS2014-08-13
38821016266386K140508ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWSHRS2014-08-14
38822029710787K130143PERSONA NATURAL TIBIA BASEPLATESJWH2013-02-22
38821574084080K123459ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEMMBH2013-02-22
38821994201273K123019LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERSLPH2012-10-22
38821666967333K122765PERSONA NATURAL TIBIA BASEPLATESJWH2012-11-09
38821934219588K121771ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEMMBH2012-11-07
38821637247515K113369ZIMMER PERSONA KNEE SYSTEMJWH2012-03-27
38821857111016K112885ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLYHWC2011-12-19
38821282420289K111447ZIMMER PERIARTICULAR SCREWSHWC2011-10-05
38821243532059K091508ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEMLPH2009-09-11
38821740798844K083654ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)HRS2009-02-26
38821289728143K083497ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILSHSB2009-02-19
38821070013881K082770ZIMMER NATURAL NAIL SYSTEM TIBIAL NAILHSB2008-12-11
38821568147720K082527ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWSHRS2008-12-18
38821829200714K073286GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEMJWH2008-03-07
38821797692944K072281NEXGEN PROLONG ALL-POLY PATELLAJWH2007-09-06
38821556775839K071107GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPONMBH2007-07-06
38821176894389K060710UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWSHWC2006-04-26
38821945415609K050723MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTSJWH2005-04-20
38821182411446K043101NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONSJWH2005-03-07
38822069645994K042271NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACESJWH2004-10-13
38821314460745K032367ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAILHSB2003-08-12
38821453252781K013991PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTSJWH2001-12-27
38821092482156K003910NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTSJWH2001-03-19
38821109980912K003478TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310LPH2001-02-05
38821296300652K002960TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353LPH2000-12-11
38821220234875
38821288488582
38821389948518
38821543838976
38821553985634
38821753132411
38822013404333
38822022944994
38822035638198
38821012583831
38821133303500
38821183715929
38821414855037
38821465819324
38821855398303
38821985803263

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH202018-03-29
JDI122021-12-10
LPH122019-11-05
HRS92015-03-04
HWC82015-11-24
HSB72015-05-29
MBH42018-05-17
KTT32015-05-01
KWY21987-07-21
HSX11988-08-03