FDA.report

Zimmer Biomet Korea Ltd.

Matched from indexed company URL: Zimmer Biomet

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
Zimmer Biomet Korea Ltd.5N2026-01-015F, Ilshin Building, 98 Hannamdae-ro, Yongsan-gu Seoul KR 04418
30143155603014315560Zimmer Biomet Centroamerica SA1N2026-01-01Oficentro Ejecutivo La Sabana Edificio 7, Piso 3 san jose CR 10101
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

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1316291152862405P950002BAK INTERBODY FUSION SYSTEMMAX 1996-09-20
3495301430643488P060037NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEMNJL2007-12-10
2155871642065196P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
3495302036867809N17755ZIMMER(R) BONE CEMENTLOD 1976-05-17
3495301546684450K994326ASCENT KNEE SYSTEMKWH2000-01-07
3495301609664671K994286ZMR HIP SYSTEM-POROUS REVISIONLPH2000-03-10
3495301473974384K994184PLR SPLINED REVISION STEMLZO2000-02-15
3495301479477712K994038MODULAR REACH HIPLPH1999-12-22
3495301889624329K993956TITANIUM PEDIATRIC FEMORAL NAILHSB1999-12-20
3495301344064367K993886EBI XFIX VISION FIXATION SYSTEMKTT1999-12-14
3495301060324026K993649EBI XFIX DFS WRISTFIX SYSTEMKTT1999-11-19
3495301820950957K993510MODIFIED BMP TROCHANTERIC PLATESHRS1999-11-16
3495301545522133K993438METAL ON METAL ACETABULAR SYSTEMKWA2000-05-18
3495301814367727K993259INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADSLPH2000-03-10
3495301269288386K993111ASCENT KNEE SYSTEMJWH1999-10-05
3495301149753952K992667ZMR HIP SYSTEM-REVISION TAPERLPH1999-10-27
3495301093991422K992301REUNITE SCREWSHWC1999-09-01
3495302029295835K992119BIO-MODULAR SHOULDER SYSTEMKWS1999-09-13
3495301202186839K992058BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEMJDI1999-07-01
3495301318788485K991990TRI-POLAR SYSTEMKWY1999-09-10
3495301142283966K991941EBI XFIX DFS RAIL SYSTEMKTT1999-08-19
3495301406099747K991807TITANIUM LOW PROFILE SCREWSLPH1999-07-08
3495301816661581K991806VHS SUPRACONDYLAR PLATE SYSTEMKTT1999-08-06
3495301367291059K991763LACTOSORB HAND SYSTEMHRS1999-07-30
3495301323858217K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COJWH1999-07-30
3495301636693907K991428ASCENT KNEE SYSTEMJWH1999-05-21
3495301355088889K991298BONE MULCH SCREW SYSTEMHWC1999-05-14
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
3495301633976488K990291LACTOSORB BONE PINHTY1999-03-23
3495302032594018K990135TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENELPH1999-07-12
1316291478061994K990005SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEMKWQ1999-02-12
1316291307662820K984578SYNERGY D2 SPINAL IMPLANTSMNI1999-03-23
3495301396097916K984390LACTOSORB PANELS AND FASTENERSHRS2000-08-07
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
3495301863557780K984028THE NEW BIO-MOORE ENDO HEADSKWL1999-01-19
3495301434771267K983910ARTHRO-SURGIMAT-1500HRX1998-11-25
3495301048171554K983509INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERTLPH1999-02-03
3495301809786446K983265DEPUY ACE COMPOSITE LOCKING NUTHTN1998-10-26
3495301637879007K983153NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTSJWH1998-12-04
3495301875892932K982981NEW ZIMMER SHOULDER SYSTEMKWT1998-12-17
3495301422002397K982953TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLESHSB1998-10-21
3495302010297042K982903SULZER ORTHOPEDICS FLUTED STEMSJWH1998-10-21
3495301855523636K982869ASCENT SYSTEMJWH1998-09-22
3495301899195295K982545BMP CABLE SYSTEMJDQ1998-10-19
3495301532182618K982367REACH HIP COMPONENTLPH1998-08-24
3495301444883188K982095LACTOSORB MENISCAL REPAIR DEVICEMAI1999-01-27
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
3495301751632964K981483EBI DFS JOINT FIXATOR, MODEL 02800KTT1998-07-08
3495301899860217K980711HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATINGLPH1998-11-12
3495301910972922K980665REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTSHRY1998-05-20
3495301546693083K974781DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAILHSB1998-03-10
3495301421515306K974558SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEMJDI1998-03-04
3495301047181137K974316HYDROFERA FEMORAL WICKEFQ1998-02-13
1316291454994467K974020SPINAL CONCEPTS, INC., CFIX CABLE SYSTEMJDQ1997-12-19
1316291141445743K973836SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEMMNH1998-03-05
3495301479025160K973775HARPOON SUTURE ANCHORSMBI1998-04-16
3495301003462873K973714VERSYS HIP SYSTEM BEADED HIP PROSTHESISLPH1997-12-24
3495302024041666K973681NATURAL-HIP COCR OFFSET STEMLZO1997-12-19
3495301145630697K973675NATURAL-HIP POROUS STEM WITH OFFSETLPH1997-12-19
3495301593909437K973412NATURAL-KNEE II CONSTRAINED KNEE SYSTEMJWH1997-12-08
3495301829469875K973357COONRAD/MORREY TOTAL ELBOW, NEW HINGE PINJDC1998-03-02
3495301544720345K973124APR POROUS HA HIP SYSTEMLPH1997-11-03
3495301877996180K972774GAS PLASMA STERILIZATIONJWH1999-05-05
3495301912884449K972501APOLLO REVISION/CONSTRAINED KNEE SYSTEMJWH1997-10-01
3495301473730300K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAILHSB1997-08-26
3495301429422554K971938REPICCI II UNICONDYLAR KNEEHRY1997-08-25
3495302064415217K971890RECOVERY PROTRUSIO CAGEJDI1997-08-07
3495301357748386K971824REACH FEMORAL HIP COMPONENTLPH1997-12-04
3495301783821861K971770APOLLO KNEE FEMORAL SPACERSJWH1997-07-31
3495301381448587K971715SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTSKWS1997-08-07
3495301636569207K970705INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLESLPH1997-05-22
3495301604148572K970300NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTILPH1997-07-03
3495301657262262K970290EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEMKTT1997-04-01
3495302042225244K970202DEPUY ACE AIM TITANIUM TIBIAL NAILHSB1997-03-21
3495301523099493K965098INTRAMEDULLARY NAIL SYSTEMHSB1997-02-28
3495301371117650K964970BIOMET BONE SCREWHWC1997-04-03
3495301891571473K964880VARI-ANGLE HIP SCREW (VHS) SYSTEMKTT1997-10-16
3495301768411482K964769VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESISLPH1997-02-13
1316291808351126K964404BACFIX SPINAL FIXATION SYSTEMKWP1997-03-26
3495301502876686K963266NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLAREDLPH1996-10-15
3495301528138419K963155INTERMOORE FRACTURE HIP STEM (MODIFY)LWJ1996-10-01
3495301642748899K963148NEXGEN COMPLETE KNEE SOLUTIONJWH1997-02-13
3495301748236162K963109HERITAGE HIP SYSTEMJDI1997-01-09
3495301512471738K962561SUPRACONDYLAR INTRAMEDULLARY NAILHSB1996-09-25
3495301836349996K962468HEDROCEL ACETABULAR RESTRICTORJDI1997-02-03
3495301226896583K962289SELECT SHOULDER COCR HUMERAL STEM COMPONENTHSD1996-08-29
3495301863451595K962238SELECT SHOULDER KEELED ALL-POLY GLENOIDSKWT1996-08-09
3495301476211118K962236SCARF THREAD-HEAD SCREWHWC1996-09-20
3495301885407476K962233TWIST-OFF SCREWHWC1996-10-03
3495301201873783K962224SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTSKWS1996-08-28
3495301301891843K961589APR FULLY TEXTURED HIP STEMLZO1996-07-09
3495302058231790K961571COCR BI-ANGULAR HUMERAL COMPONENTKWT1996-08-05
3495301614471356K961260KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAYHSD1997-04-02
3495301497122080K960658COLLARLESS POLISHED TAPER HIP PROSTHESISJDI1996-07-16
3495301005770470K960626MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)JDI1996-04-18
3495301287082463K960535APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLAJWH1996-04-23
3495301978111778K960363BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143MJT1997-02-18
3495301332644007K960279NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACESJWH1996-04-26
3495301200692299K960278COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENTJDI1996-07-25
3495301918003093K960258NATURAL HIP SYSTEMJDI1996-07-12
3495301364509701K955778NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEMHRY1996-03-08
3495301410841838K955473GAMMA SYSTEMJDI1996-02-16
3495301260075767K955472ACE HUMERUS & RADIUS PLATESHRS1996-04-01
3495302053062569K955033RIM FLARE ACETABULAR COMPONENTLPH1996-01-31
3495301161448134K954854INTERMOORE FRACTURE HIP STEMLWJ1996-02-15
3495301455096509K954800APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)MEH1996-04-25
3495301821839162K954744ZCH ALPHA SYSTEMJDI1996-01-23
3495301469727280K954698TRILOGY ACETABULAR COMPONENT 7MM OFFSETLPH1996-01-17
3495301026588757K954555VERSA-FX FEMORAL FIXATION SYSTEMKTT1996-01-26
3495301525931151K954443LACTOSORB SUTURE ANCHORJDR1996-01-31
3495301123875254K953925FINE GRAIN CAST COBALT CHROMIUM HIP STEMSLZO1996-01-31
2155871577055219K953925FINE GRAIN CAST COBALT CHROMIUM HIP STEMSLZO1996-01-31
3495301620532695K953490TRILOGY ACETABULAR SHELL & LINERS 36MMLPH1995-10-20
3495301031353933K953337BETA HIP PROSTHESISLPH1996-01-22
3495301985340864K951658LACTOSORB POP RIVETJDR1995-07-25
3495301437867239K951357EBI SMALL EXTERNAL FIXATOR (S/E/F/)KTT1995-06-21
1316291057687112K950709SYNERGY TI ANTERIOR SPINAL SYSTEMKWQ1995-10-25

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LPH722015-02-10
JWH652018-03-29
JDI552020-07-16
HRS482018-04-06
KTT422015-12-30
HWC412020-02-24
NKB332015-08-31
HSB322014-10-22
KWQ252014-11-05
KWP212014-12-15
KWA202011-09-30
MBH172016-05-10
KRO172013-10-24
MBI162020-01-16
LZO162010-02-04
PHX142020-04-15
KWT112011-03-15
HRY102007-02-02
KWS92021-12-10
MNI92009-12-10
HAW82019-02-07
JDC82019-01-28
HTY82004-07-30
OLO72022-10-04
MAX72014-01-30
LXT72009-03-11
KWY72008-10-31
HRX72008-09-09
HSX62016-11-03
MQP62007-08-31
HSD62005-09-29
MEH62002-05-31
MBF52020-10-28
OVD52014-10-09
KWZ52008-01-07
MNH52006-07-25
JDQ42016-01-15
JDW42011-02-17
JDR42006-07-25
LWJ42000-11-15

PMA

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

2022-11-28

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

2022-11-09

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...

PMN

GUDID

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