FDA.reportPublic FDA data

Zimmer Biomet Korea Ltd.

Matched from indexed company URL: ZIMMER, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Zimmer Biomet Korea Ltd.5N2026-01-015F, Ilshin Building, 98 Hannamdae-ro, Yongsan-gu Seoul KR 04418
15263501526350ZIMMER SURGICAL, INC.1Y2026-01-01200 WEST OHIO AVE. Dover OH US 44622
18225651000220733ZIMMER, INC.1Y2026-01-011800 W. Center Street WARSAW IN US 46580
20831872083187ZIMMER MEDIZINSYSTEMS CORP1Y2026-01-013 Goodyear Suite B Irvine CA US 92618
26489201000132037ZIMMER MANUFACTURING B.V.1N2026-01-01ROUTE 1, KM. 123.4, BLDG. 2 TURPEAUX INDUSTRIAL PARK MERCEDITA PR US 00715
80107207759ZIMMER MEDIZINSYSTEME GMBH1N2026-01-01JUNKERSSTRASSE 9 NEU-ULM Bavaria DE 89231
30057510283005751028Zimmer Trabecular Metal Technology, Inc.1N2026-01-0110 POMEROY RD. Parsippany NJ US 07054
30079638273007963827Zimmer Orthopedic Mfg Ltd1N2026-01-01Building No 2 East Park Shannon Industrial Estate Shannon Clare IE 0000000
30088121733008812173Zimmer Knee Creations, Inc.1N2026-01-0156 E Bell Dr Warsaw IN US 46582
30131760803013176080ZIMMER PTE. LTD.1N2026-01-01401 Commonwealth Drive #06-03 How Par Techno Centre Singapore South East SG 149598
30143155603014315560Zimmer Biomet Centroamerica SA1N2026-01-01Oficentro Ejecutivo La Sabana Edificio 7, Piso 3 san jose CR 10101
30203932633020393263Zimmer U.S., Inc. Connected Health1N2026-01-01601 5th St. NW, Suite 200 Grand Rapids MI US 49504
20231412023141ZIMMER DENTAL INC.1N2020-04-251900 ASTON AVE CARLSBAD CA US 92008
30038530723007472424Zimmer Spine1N2020-04-25CITE MONDIALE 23 PARVIS DES CHARTRONS BORDEAUX Aquitaine FR 33080
30091741793009174179ZIMMER BIOMET SPINE. INC1Y2020-04-255400 Meltech Blvd Ste 119 Memphis TN US 38118
30160509403016050940Zimmer Biomet Center of Excellence1N2020-04-257437 Polk Lane Olive Branch MS US 38654

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
00889024081024XtraFix® Large External Fixation System - 00-5207-024-30+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com
00889024081055XtraFix® Large External Fixation System - 00-5207-032-30+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com
00889024081062XtraFix® Large External Fixation System - 00-5207-040-10+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1316291152862405P950002BAK INTERBODY FUSION SYSTEMMAX1996-09-20
3495301430643488P060037NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMNJL2007-12-10
38702021225455P060037NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMNJL2007-12-10
1094092021225455P060037NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMNJL2007-12-10
2155871642065196P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
38701305223560N17755ZIMMER(R) BONE CEMENTLOD1976-05-17
2126492036867809N17755ZIMMER(R) BONE CEMENTLOD1976-05-17
3495302036867809N17755ZIMMER(R) BONE CEMENTLOD1976-05-17
2126491546684450K994326ASCENT KNEE SYSTEMKWH2000-01-07
3495301546684450K994326ASCENT KNEE SYSTEMKWH2000-01-07
38701050060098K994286ZMR HIP SYSTEM-POROUS REVISIONLPH2000-03-10
3495301609664671K994286ZMR HIP SYSTEM-POROUS REVISIONLPH2000-03-10
2126491473974384K994184PLR SPLINED REVISION STEMLZO2000-02-15
3495301473974384K994184PLR SPLINED REVISION STEMLZO2000-02-15
2126491479477712K994038MODULAR REACH HIPLPH1999-12-22
3495301479477712K994038MODULAR REACH HIPLPH1999-12-22
2126491889624329K993956TITANIUM PEDIATRIC FEMORAL NAILHSB1999-12-20
3495301889624329K993956TITANIUM PEDIATRIC FEMORAL NAILHSB1999-12-20
3495301344064367K993886EBI XFIX VISION FIXATION SYSTEMKTT1999-12-14
2126491344064367K993886EBI XFIX VISION FIXATION SYSTEMKTT1999-12-14
2126491060324026K993649EBI XFIX DFS WRISTFIX SYSTEMKTT1999-11-19
3495301060324026K993649EBI XFIX DFS WRISTFIX SYSTEMKTT1999-11-19
2126491820950957K993510MODIFIED BMP TROCHANTERIC PLATESHRS1999-11-16
3495301820950957K993510MODIFIED BMP TROCHANTERIC PLATESHRS1999-11-16
2126491545522133K993438METAL ON METAL ACETABULAR SYSTEMKWA2000-05-18
3495301545522133K993438METAL ON METAL ACETABULAR SYSTEMKWA2000-05-18
2126491814367727K993259INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADSLPH2000-03-10
3495301814367727K993259INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADSLPH2000-03-10
38701879211623K993259INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADSLPH2000-03-10
2126491269288386K993111ASCENT KNEE SYSTEMJWH1999-10-05
3495301269288386K993111ASCENT KNEE SYSTEMJWH1999-10-05
3495301149753952K992667ZMR HIP SYSTEM-REVISION TAPERLPH1999-10-27
38701957938625K992667ZMR HIP SYSTEM-REVISION TAPERLPH1999-10-27
2126491093991422K992301REUNITE SCREWSHWC1999-09-01
3495301093991422K992301REUNITE SCREWSHWC1999-09-01
2126492029295835K992119BIO-MODULAR SHOULDER SYSTEMKWS1999-09-13
3495302029295835K992119BIO-MODULAR SHOULDER SYSTEMKWS1999-09-13
3495301202186839K992058BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEMJDI1999-07-01
2126491318788485K991990TRI-POLAR SYSTEMKWY1999-09-10
3495301318788485K991990TRI-POLAR SYSTEMKWY1999-09-10
2126491142283966K991941EBI XFIX DFS RAIL SYSTEMKTT1999-08-19
3495301142283966K991941EBI XFIX DFS RAIL SYSTEMKTT1999-08-19
2126491406099747K991807TITANIUM LOW PROFILE SCREWSLPH1999-07-08
3495301406099747K991807TITANIUM LOW PROFILE SCREWSLPH1999-07-08
2126491816661581K991806VHS SUPRACONDYLAR PLATE SYSTEMKTT1999-08-06
3495301816661581K991806VHS SUPRACONDYLAR PLATE SYSTEMKTT1999-08-06
2126491367291059K991763LACTOSORB HAND SYSTEMHRS1999-07-30
3495301367291059K991763LACTOSORB HAND SYSTEMHRS1999-07-30
38701321022132K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
38821321022132K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
1094091321022132K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
2126491323858217K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
3495301323858217K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
2126491636693907K991428ASCENT KNEE SYSTEMJWH1999-05-21
3495301636693907K991428ASCENT KNEE SYSTEMJWH1999-05-21
2126491355088889K991298BONE MULCH SCREW SYSTEMHWC1999-05-14
3495301355088889K991298BONE MULCH SCREW SYSTEMHWC1999-05-14
38701115836957K991143MAGNA-ROM 21 KNEE SYSTEEMJWH1999-06-11
38671769936641K991038VASO PRESS DVT SYSTEM, MODELS VP500, VP501JOW2000-06-22
3495301474020183K990830MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTSLPH2000-04-11
2155871772665346K990830MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTSLPH2000-04-11
38811421425663K990330CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZJDI2000-03-01
2126491633976488K990291LACTOSORB BONE PINHTY1999-03-23
3495301633976488K990291LACTOSORB BONE PINHTY1999-03-23
38701415906026K990135TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENELPH1999-07-12
38821415906026K990135TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENELPH1999-07-12
2126492032594018K990135TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENELPH1999-07-12
3495302032594018K990135TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENELPH1999-07-12
1316291478061994K990005SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEMKWQ1999-02-12
1316291307662820K984578SYNERGY D2 SPINAL IMPLANTSMNI1999-03-23
2126491396097916K984390LACTOSORB PANELS AND FASTENERSHRS2000-08-07
3495301396097916K984390LACTOSORB PANELS AND FASTENERSHRS2000-08-07
2126491935627807K984296LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENTLPH1999-02-18
3495301935627807K984296LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENTLPH1999-02-18
3495301364715020K984209STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PEDHWC1999-02-03
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
3495301863557780K984028THE NEW BIO-MOORE ENDO HEADSKWL1999-01-19
2126491434771267K983910ARTHRO-SURGIMAT-1500HRX1998-11-25
3495301434771267K983910ARTHRO-SURGIMAT-1500HRX1998-11-25
2126491048171554K983509INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERTLPH1999-02-03
3495301048171554K983509INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERTLPH1999-02-03
38701297342281K983509INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERTLPH1999-02-03
2126491809786446K983265DEPUY ACE COMPOSITE LOCKING NUTHTN1998-10-26
3495301809786446K983265DEPUY ACE COMPOSITE LOCKING NUTHTN1998-10-26
3495301637879007K983153NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTSJWH1998-12-04
2126491637879007K983153NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTSJWH1998-12-04
38701967241408K983153NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTSJWH1998-12-04
38701823548274K982981NEW ZIMMER SHOULDER SYSTEMKWT1998-12-17
2126491875892932K982981NEW ZIMMER SHOULDER SYSTEMKWT1998-12-17
3495301875892932K982981NEW ZIMMER SHOULDER SYSTEMKWT1998-12-17
3495301422002397K982953TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLESHSB1998-10-21
2126491422002397K982953TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLESHSB1998-10-21
38701027126450K982903SULZER ORTHOPEDICS FLUTED STEMSJWH1998-10-21
2126492010297042K982903SULZER ORTHOPEDICS FLUTED STEMSJWH1998-10-21
3495302010297042K982903SULZER ORTHOPEDICS FLUTED STEMSJWH1998-10-21
2126491855523636K982869ASCENT SYSTEMJWH1998-09-22
3495301855523636K982869ASCENT SYSTEMJWH1998-09-22
38811885577698K982751IMPLEX SCREW AND WASHER SYSTEMMBI1999-02-01
2126491899195295K982545BMP CABLE SYSTEMJDQ1998-10-19
3495301899195295K982545BMP CABLE SYSTEMJDQ1998-10-19
3495301532182618K982367REACH HIP COMPONENTLPH1998-08-24
2126491532182618K982367REACH HIP COMPONENTLPH1998-08-24
38661781194979K982305SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENTDZE1998-09-22
2126491444883188K982095LACTOSORB MENISCAL REPAIR DEVICEMAI1999-01-27
3495301444883188K982095LACTOSORB MENISCAL REPAIR DEVICEMAI1999-01-27
2126491364105417K981967WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCREMBI1998-07-17
3495301364105417K981967WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCREMBI1998-07-17
3495301707994573K981789LORENZ PECTUS SUPPORT BAR STABILIZERHRS1998-07-13
2126491751632964K981483EBI DFS JOINT FIXATOR, MODEL 02800KTT1998-07-08
3495301751632964K981483EBI DFS JOINT FIXATOR, MODEL 02800KTT1998-07-08
38701108471105K980711HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATINGLPH1998-11-12
2126491899860217K980711HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATINGLPH1998-11-12
3495301899860217K980711HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATINGLPH1998-11-12
3495301910972922K980665REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTSHRY1998-05-20
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
3495301546693083K974781DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAILHSB1998-03-10
3495301421515306K974558SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEMJDI1998-03-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH2322025-03-06
LPH2072026-02-04
JDI1582025-07-31
HRS1212018-04-06
HWC972020-02-24
KTT972015-12-30
HSB822026-03-12
MBH612026-03-09
LZO572026-04-27
KWA412011-10-07
KRO402015-02-06
DZE392014-10-28
NKB362015-08-31
KWT332019-06-05
PHX312024-05-15
MBI262020-01-16
KWS252021-12-10
KWQ252014-11-05
JDC242019-01-28
HRY242007-02-02
KWP232014-12-15
HSX202020-03-17
KWY202008-10-31
HTY182015-05-01
NHA152015-05-01
KWZ152010-12-03
LWJ152000-11-15
JOW142016-07-13
LXT142009-03-11
HSD142005-09-29
MEH142002-05-31
MBF132026-04-13
JDQ122016-01-15
HRX122008-09-09
HAW112019-02-07
OLO102023-03-29
JDR102006-07-25
MNI92009-12-10
JDW82011-02-17
MQP82007-08-31

PMA#

LDR Spine Mobi-C® Cervical Disc Prosthesis

2022-11-28

Zimmer Biomet Spine, Inc.10225 Westmoor Drivewestminster, CO 80021 PMA NumberP110009 Supplement NumberS034 Date Received11/08/2022 Decision Date11/28/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process...

LDR Spine Mobi-C® Cervical Disc Prosthesis

2022-11-28

Zimmer Biomet Spine, Inc.10225 Westmoor Drivewestminster, CO 80021 PMA NumberP110002 Supplement NumberS034 Date Received11/08/2022 Decision Date11/28/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process...

LDR Spine Mobi-C® Cervical Disc Prosthesis

2022-11-09

Zimmer Biomet Spine, Inc.10225 Westmoor Drivewestminster, CO 80021 PMA NumberP110009 Supplement NumberS032 Date Received01/21/2022 Decision Date11/09/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type135 Review Track For 30-day Notice Supp...

NexGen® LPS-Flex/LPS Mobile Bearing Knee System

2022-10-06

ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS082 Date Received09/30/2022 Decision Date10/06/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacture...

NexGen® LPS-Flex / LPS-Mobile Bearing Knee

2022-08-15

ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS080 Date Received07/25/2022 Decision Date08/15/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change ...

NexGen LPS-Flex/ LPS-Mobile Bearing Knee

2022-05-20

ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS079 Date Received05/09/2022 Decision Date05/20/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacture...

NexGen LPS-Flex/ LPS-Mobile Bearing Knee System

2022-03-23

ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS078 Date Received03/07/2022 Decision Date03/23/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacture...

153 records. Showing 1-40. Next

PMN#

PTG-05

2024-07-21

Zimmer Medizinsysteme GmbH

RFG-01

2024-07-15

Zimmer Medizinsysteme GmbH

MFG-05

2023-10-05

Zimmer Medizinsysteme GmbH

ThermoTK

2023-05-25

Zimmer Medizinsysteme GmbH

c1Trac

2023-05-16

Zimmer Medizinsysteme GmbH

CoolTone

2022-04-01

Zimmer MedizinSysteme GmbH

Cryo 7

2022-02-04

Zimmer MedizinSysteme GmbH

EmField

2021-02-19

Zimmer MedizinSysteme GmbH

200 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next