FDA.reportPublic FDA data

Biomet

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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 GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00880304810990Cement Delivery System - 110030623+0330475759100eufrvra@zimmerbiomet.com
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 key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1432581626436159K993886EBI XFIX VISION FIXATION SYSTEMKTT1999-12-14
1432581795944773K993465DEPUY ACE CALCANEAL PERI-ARTICULAR PLATEHRS2000-01-11
1432581756435945K990120MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATEHSB1999-02-01
1432581556062427K984458DEPUY ACE SPIDER PLATEHRS1998-12-31
1432581399677586K983853DEPUY ACE TIMAX META PLATEHRS1998-12-22
1432581726188136K981775DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATEHRS1998-07-29
1432581357699056K980370BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATORKTT1998-04-14
1432581013120852K972629DEPUY AE TK2 HIP SCREW SYSTEMKTT1997-10-09
1432581922961573K955472ACE HUMERUS & RADIUS PLATESHRS1996-04-01
1432581632835752K9544856.5MM SOLID CANCELLOUS BONE SCREWHWC1995-10-31
1432581398588779K951357EBI SMALL EXTERNAL FIXATOR (S/E/F/)KTT1995-06-21
1432581282054039K930592ACE UNIVERSAL RECONSTRUCTION PLATEHRS1993-07-26
1432581662798199K926047ACE 8.0MM CANNULATED CANCELLOUS BONE SCREWHWC1993-03-31
1432581131010951K920738ACE 100 DEGREES TUBULAR PLATEHRS1992-07-27
1432581886330935K905774THACKRAY TITANIUM MINI-PLATING SYSTEMHRS1991-06-13
1432581725833921K905595ACE RECONSTRUCTIVE PLATEHRS1991-03-14
1432581325222230K905048ACE 3.5MM CORTICAL BONE SCREWHWC1991-01-30
1432581362919644K903811ACE CANNULATED CORTICAL BONE SCREWHWC1990-10-16
1432581284858361K903810ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREWHWC1990-10-16
1432581741787925K895107ACE ORTHOPAEDIC WASHERSHTN1989-09-11
1432581616182881K882831ACE CANCELLOUS BONE SCREWHWC1988-08-01
1432581053925641K874672ACE CORTICAL LAG SCREWHWC1987-12-11
1432581434530858K874670ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREWHWC1987-12-17
1432581487460650K872859ACE CANCELLOUS BONE SCREWHWC1987-08-17
1432581841615718K831005WIRE & STEINMAN PINSHTY1983-05-18
1432581433656975K782123MULTIPLICITY OF PRODUCTSHRS1979-01-10
1432581242813483K173767A. L. P. S. Clavicle Plating SystemHRS2018-04-06
1432582062545106K162424Ulna Plating SystemHRS2016-10-12
1432581236935004K160058Biomet Variable Pitch Compression Screw SystemHWC2016-03-09
1432581850732016K143697Biomet Proximal Humerus Plating SystemHRS2015-03-30
1432581120862478K140622DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATEHRS2014-05-13
1432581373499143K133939MODIFIED DISTAL RADIUS PLATING SYSTEMHRS2014-04-01
1432581143607025K132704DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWLXT2013-10-09
1432581734292491K1318672.5MM INLINE FUSION PLATEHRS2013-10-29
1432581681680316K131670LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)HRS2013-07-03
1432581938057331K112345DISTAL VOLAR RADIUS PLATING SYSTEMSLXT2011-10-31
1432581553051303K111663TRAUMA INTERNAL FIXATION SYSTEMSHRS2012-03-12
1432581192002887K103408POSTERIOR LATERAL PLATESHRS2010-12-16
1432581397592881K103001ROCKWOOD CLAVICLE PINSJDW2011-02-17
1432582004118710K101421MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204HRS2010-06-15
1432581593614963K101240CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467HRS2010-07-23
1432581956129526K093474DEPUY FRACTURE AND FUSION PLATING SYSTEMHRS2010-02-02
1432581094999520K091294LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,HRS2009-07-24
1432581974463723K090877PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWSHRS2009-06-26
1432581273417979K090374STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(SLXT2009-03-11
1432581049292908K083843LOCKING ANATOMIC & COMPOSITE PLATING SYSTEMHRS2009-03-20
1432581239669680K0833642.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424HRS2008-12-11
1432582027311427K082300ANATOMIC LOCKING PLATING SYSTEMHRS2009-02-18
1432581060222224K081546SMALL BONE LOCKING PLATING SYSTEMHRS2008-08-26
1432581974257136K081244LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONSKTT2008-07-30
1432581729721849K072832ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEMHRS2007-12-14
1432581541013109K0724234.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.HRS2007-11-07
1432581339672181K072083SMALL FRAGMENT LOCKING PLATING SYSTEMHRS2007-10-25
1432581789775559K061748FRAGMENT PLATE SYSTEMKTT2006-07-17
1432581797003778K061098EBI OPTILOCK PERIARTICULAR PLATING SYSTEMHRS2006-05-24
1432581181799559K060969POLYAX LOCKED PLATING SYSTEMHRS2006-05-12
1432581692102720K060864MULTIDIRECTIONAL THREADED PEGLXT2006-04-28
1432581849587822K060294DIAPHYSEAL PLATEHRS2006-03-22
1432581777078599K060290SHOULDER FIXATION SYSTEMLXT2006-02-27
1432581852910415K052294SHOULDER NAIL PLATEHRS2005-10-21
1432581358155713K052248DORSAL NAIL PLATE, ANATOMICALHRS2005-09-14
1432581054879940K050932DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEMLXT2005-04-26
1432581685248400K042237EBI PERIARTICULAR PLATING SYSTEMHRS2004-09-16
1432581388011319K042059SHOULDER FIXATION SYSTEMLXT2004-09-30
1432581894469844K041157MODIFICATION TO SMALL BONE FIXATION SYSTEMHTY2004-07-30
1432581075692495K041081FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRESKTT2004-07-01
1432581370636442K040833MODIFICATION TO EBI XFIX VISION FIXATION SYSTEMKTT2004-04-29
1432581366003505K030706EBI DYNAFIX COMPRESSION BONE SCREWHWC2003-03-20
1432582034969050K020403MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATORKTT2002-03-08
1432581655452773K020141MODIFICATION TO EBI XFIX VISION FIXATION SYSTEMKTT2002-02-05
1432582041282934K014194MODIFICATION TO EBI XFIX VISION FIXATION SYSTEMKTT2002-01-17
1432581142576299K003235PE.R.I. II KNEE FRACTURE SYSTEMHRS2000-11-06
1432581008905633
1432581022071882
1432581036000770
1432581042886288
1432581049130320
1432581183745060
1432581221146102
1432581406813826
1432581420848131
1432581440533375
1432581499918026
1432581578917869
1432581581628234
1432581620162590
1432581625976748
1432581699964372
1432581718490790
1432581772590065
1432581865537451
1432581932732661
1432582045841392
1432582046662997

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS382018-04-06
HWC112016-03-09
KTT112008-07-30
LXT72013-10-09
HTY22004-07-30
JDW12011-02-17
HSB11999-02-01
HTN11989-09-11

PMN#

GUDID#