FDA.report

BIOMET MICROFIXATION

Matched from indexed company URL: Biomet, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
10323471032347BIOMET MICROFIXATION1N2026-01-011520 Tradeport Dr Jacksonville FL US 32218
18250341825034BIOMET, INC.1Y2026-01-0156 E Bell Dr Po Box 587 WARSAW IN US 46581
30028065353002806535BIOMET UK LTD.1N2026-01-01WATERTON INDUSTRIAL ESTATE BRIDGEND GB CF31 3XA
30068096283006809628Biomet Mexico1N2026-01-01Torre Jade Av. Periferico Sur No. 4829 401. Col Parques del Pedregal, Mexico City Ciudad de Mexico MX 14010
30108308343004525092BiometerPlus USA, Inc.1Y2026-01-0148531 Warm Springs Blvd., #416 Fremont CA US 94539
30109583773010958377Biometrix sro1N2026-01-01Vicenzy 16 Samorin Bratislavsky SK 93101
96109183002806539Biomet UK Ltd1N2020-04-25Dorcan One Hundred Murdock Road Dorcan Industrial Estate Swindon Wiltshire GB SN3 5HY
30035067153003506715Biomet1N2020-04-256303 Blue Lagoon Drive Suite 100 Miami FL US 33126

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00887868214578BIOMET® BONE CEMENT R - 110035368+0330475759100eufrvra@zimmerbiomet.com
03599870107898TESS BASE - A1700380+0330475759100eufrvra@zimmerbiomet.com
03599870108505T.E.S.S® LID - A1700382+0330475759100eufrvra@zimmerbiomet.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
282671013060902P020016WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEMLZD2005-09-21
39461366094108P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
1645581366094108P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
1649941366094108P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
39461241100863K994326ASCENT KNEE SYSTEMKWH2000-01-07
39461650632723K994184PLR SPLINED REVISION STEMLZO2000-02-15
39461577585115K994038MODULAR REACH HIPLPH1999-12-22
39462045415813K993956TITANIUM PEDIATRIC FEMORAL NAILHSB1999-12-20
39461626436159K993886EBI XFIX VISION FIXATION SYSTEMKTT1999-12-14
1432581626436159K993886EBI XFIX VISION FIXATION SYSTEMKTT1999-12-14
39461562905539K993649EBI XFIX DFS WRISTFIX SYSTEMKTT1999-11-19
39462013354644K993510MODIFIED BMP TROCHANTERIC PLATESHRS1999-11-16
39461795944773K993465DEPUY ACE CALCANEAL PERI-ARTICULAR PLATEHRS2000-01-11
1432581795944773K993465DEPUY ACE CALCANEAL PERI-ARTICULAR PLATEHRS2000-01-11
39461110631126K993159MAXIM KNEE SYSTEMJWH1999-10-14
39461632752208K993111ASCENT KNEE SYSTEMJWH1999-10-05
282671317338145K992961LORENZ SMALL FRAGMENT SYSTEMHRS1999-11-08
282671859980973K992952LORENZ DISTRACTION SYSTEMMQN1999-11-19
39461233707316K992899BIO-MODULAR SHOULDER OFFSET HUMERAL HEADSKWS1999-10-21
39461922983824K992515EBI XFIX DFS OPTIROM ELBOW FIXATORKTT1999-08-17
39461654689651K992367EBI XFIX DYNAFIX SYSTEM HA COATED SCREWSHWC1999-09-23
282671472800172K992355LACTOSORB TRAUMA PLATING SYSTEMHRS1999-12-20
39461596278752K992355LACTOSORB TRAUMA PLATING SYSTEMHRS1999-12-20
39462024954188K992301REUNITE SCREWSHWC1999-09-01
39461544138925K992158LACTOSORB SHEETSJEY1999-08-20
282671684830220K992158LACTOSORB SHEETSJEY1999-08-20
39461068456792K992119BIO-MODULAR SHOULDER SYSTEMKWS1999-09-13
39461821866250K992058BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEMJDI1999-07-01
39461999719050K991990TRI-POLAR SYSTEMKWY1999-09-10
39461008928096K991941EBI XFIX DFS RAIL SYSTEMKTT1999-08-19
39461429924188K991807TITANIUM LOW PROFILE SCREWSLPH1999-07-08
39461091166684K991806VHS SUPRACONDYLAR PLATE SYSTEMKTT1999-08-06
39461129819197K991763LACTOSORB HAND SYSTEMHRS1999-07-30
39461031188119K991649DEPUY ROCKWOOD CLAVICLE PINJDW1999-07-14
39461801357935K991428ASCENT KNEE SYSTEMJWH1999-05-21
39461425224317K991298BONE MULCH SCREW SYSTEMHWC1999-05-14
39461168462544K990830MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTSLPH2000-04-11
39461511531225K990392DEPUY ACE SPIDER PLATEHRS1999-03-23
39461515916051K990291LACTOSORB BONE PINHTY1999-03-23
282671879130763K990290CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLERGXP1999-11-18
39461756435945K990120MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATEHSB1999-02-01
1432581756435945K990120MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATEHSB1999-02-01
39461838176444K990032MODULAR PROTUSIO CUPJDI1999-02-18
39461556062427K984458DEPUY ACE SPIDER PLATEHRS1998-12-31
1432581556062427K984458DEPUY ACE SPIDER PLATEHRS1998-12-31
39461800594641K984408130 MODIFIED INTEGRAL FEMORAL COMPONENTLPH1999-02-12
39461985899332K984390LACTOSORB PANELS AND FASTENERSHRS2000-08-07
39461944111078K984296LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENTLPH1999-02-18
39461929114029K984209STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PEDHWC1999-02-03
39461908906200K984054AGC V2 REVISION KNEE SYSTEMJWH1999-07-30
39461740273925K984028THE NEW BIO-MOORE ENDO HEADSKWL1999-01-19
39461875928523K983910ARTHRO-SURGIMAT-1500HRX1998-11-25
39461399677586K983853DEPUY ACE TIMAX META PLATEHRS1998-12-22
1432581399677586K983853DEPUY ACE TIMAX META PLATEHRS1998-12-22
282671156603292K983728LORENZ IMF SCREWDZL1999-05-13
39461596900666K983710150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISHJDI1998-12-02
39462038164680K983265DEPUY ACE COMPOSITE LOCKING NUTHTN1998-10-26
39461668063198K983035CUSTOM FLANGED ACETABULAR COMPONENTLPH1998-11-23
39461847228255K982953TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLESHSB1998-10-21
39461213336108K982869ASCENT SYSTEMJWH1998-09-22
39461308984742K982545BMP CABLE SYSTEMJDQ1998-10-19
39461104430674K982497ARTHROTEK INTERFERENCE SCREWHWC1998-10-16
39461162269099K982367REACH HIP COMPONENTLPH1998-08-24
39461437423604K982095LACTOSORB MENISCAL REPAIR DEVICEMAI1999-01-27
39461760728559K981967WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCREMBI1998-07-17
39461293298888K981798LACTOSORB POP RIVETJDR1998-07-13
282671449754667K981789LORENZ PECTUS SUPPORT BAR STABILIZERHRS1998-07-13
39461726188136K981775DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATEHRS1998-07-29
1432581726188136K981775DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATEHRS1998-07-29
39461070140916K981483EBI DFS JOINT FIXATOR, MODEL 02800KTT1998-07-08
282671154749478K98107020-HOLE ADAPTATION PLATEJEY1998-05-20
282671581415731K980927LACTOSORB PANELS AND FASTENERSJEY1998-06-05
39461981331789K980927LACTOSORB PANELS AND FASTENERSJEY1998-06-05
39461940597226K980665REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTSHRY1998-05-20
282672031446665K980512LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREWJEY1998-05-11
39462005344499K980428BIOMET BIAXIAL TOTAL ELBOWJDC1998-05-05
39461357699056K980370BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATORKTT1998-04-14
1432581357699056K980370BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATORKTT1998-04-14
39461130470892K974781DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAILHSB1998-03-10
39461374710472K974558SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEMJDI1998-03-04
282671229699384K974309LACTOSORB PANELSHRS1998-01-30
282671877518770K974136CRANIOFACIAL ANCHORSMBI1998-01-30
39462052631081K973775HARPOON SUTURE ANCHORSMBI1998-04-16
282671188307185K973080SURGICAL VASCULAR CLAMPDXC1998-02-23
39461493802268K972860CURVTEK TSR SYSTEMHSZ1997-10-31
39461013120852K972629DEPUY AE TK2 HIP SCREW SYSTEMKTT1997-10-09
1432581013120852K972629DEPUY AE TK2 HIP SCREW SYSTEMKTT1997-10-09
282671679758144K972420LORENZ PECTUS SUPPORT BARHRS1997-08-11
282671369293463K972322LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATESJEY1997-08-18
39461263397641K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAILHSB1997-08-26
282671876207441K972074SUCTION INSTRUMENTATIONGCX1997-07-25
39461640282774K971996MEDIVISION ARTHROSCOPHRX1997-07-31
39461289281681K971938REPICCI II UNICONDYLAR KNEEHRY1997-08-25
39461608362543K971890RECOVERY PROTRUSIO CAGEJDI1997-08-07
39461537768154K971870LACTOSORB TRAUMA PLATING SYSTEMHRS1997-08-19
282671600712248K971870LACTOSORB TRAUMA PLATING SYSTEMHRS1997-08-19
39461076344651K971824REACH FEMORAL HIP COMPONENTLPH1997-12-04
39461444474741K971069TWIST-OFF (TM) SCREWHWC1997-07-09
39461485241148K970503DEPUY ACE TROCHANTERIC SIDE PLATEHRS1997-04-30
39461182374070K970501PEGGED ACETABULAR COMPONENTLPH1997-04-30
39461112933415K970290EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEMKTT1997-04-01
39461488430654K970202DEPUY ACE AIM TITANIUM TIBIAL NAILHSB1997-03-21
39461523248117K964970BIOMET BONE SCREWHWC1997-04-03
39461298691986K964880VARI-ANGLE HIP SCREW (VHS) SYSTEMKTT1997-10-16
39461368889618K964226MEMORY STAPLE (20 SIZES AVAILABLE)JDR1997-08-05
39461270135109K962236SCARF THREAD-HEAD SCREWHWC1996-09-20
39461633115801K962233TWIST-OFF SCREWHWC1996-10-03
39461065175333K961571COCR BI-ANGULAR HUMERAL COMPONENTKWT1996-08-05
39461493224528K961433EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWSKTT1996-06-28
39461008034565K961260KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAYHSD1997-04-02
39461732525409K960984SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERSJDI1996-09-17
39462023480787K960856KONSTRUCT PATELLAR COMPONENTJWH1996-11-27
39461224844134K960642NANCY NAILHTY1996-05-17
39461718918488K960363BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143MJT1997-02-18
39461670635293K960303FENNING FEMORAL COMPONENTLPH1996-06-21
282671104533822K955729LACTOSORB TRAUMA PLATING SYSTEMHRS1996-02-14
39461923715673K955729LACTOSORB TRAUMA PLATING SYSTEMHRS1996-02-14
39461922961573K955472ACE HUMERUS & RADIUS PLATESHRS1996-04-01
1432581922961573K955472ACE HUMERUS & RADIUS PLATESHRS1996-04-01
39461191450061K955388ACE-DUPONT COMPOSITE RINGSLXT1996-01-31

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HRS1382025-07-25
KTT652011-12-15
HWC642020-02-24
LPH542016-05-26
JWH452017-07-28
JDI432015-10-14
HSB352018-12-14
MBI302020-11-10
KWA272011-09-30
JEY242021-08-05
LZO242020-12-08
PHX172026-04-15
LXT172013-10-09
KRO162014-05-28
HTY142024-05-22
HRY122014-03-28
MBF112020-10-28
JDR112015-10-02
KWT102023-07-12
MBH102016-05-10
JDW82011-02-17
MBB72022-12-28
HRX72008-09-09
JEC71994-06-16
JDG62022-02-07
KWS62021-12-10
HSD62005-09-29
KWY52008-10-31
GAT42017-02-17
KRR42015-01-30
HTN42014-07-18
MQV42009-04-02
MEH42002-05-31
LLZ32023-07-25
HBE32022-11-15
JDS32020-02-20
FMF32020-01-06
JDO32018-02-07
JDC32016-02-03
GEI32014-07-31

PMA

Oxford® Partial Knee System

2022-10-25

BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS103 Date Received09/29/2022 Decision Date10/25/2022 Product Code NRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Rea...

Oxford Partial Knee System

2022-07-14

BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS102 Date Received06/14/2022 Decision Date07/14/2022 Product Code NRA  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Su...

Oxford Partial Knee System

2022-04-04

BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS101 Date Received03/11/2022 Decision Date04/04/2022 Product Code NRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Rea...

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PMN

200 records. Showing 1-40. Next

GUDID