FDA.reportPublic FDA data

Zimmer Biomet G.K.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30127254513012725451Zimmer Biomet G.K.1N2027-01-016-15 Shinmachi Hiratsuka Kanagawa JP 254-0076

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2179511202186839K992058BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEMJDI1999-07-01
2179511562366225K892228INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEMHRS1989-10-06
2179511961110158K171054Biomet Knee Joint Replacement ProsthesesJWH2017-07-28
2179511105659548K153657Vanguard XP Knee SystemMBH2016-05-10
2179511180969069K132873VANGUARD XP KNEE SYSTEMMBH2013-12-11
2179511012107756K121874G7 ACETABULAR SYSTEMPBI2012-11-23
2179511778511734K120030TAPERLOC COMPLETE SIZE 4MM AND XR 123LPH2012-08-17
2179511066447681K110400TAPERLOC COMPLETE MICROPLASTY STEMKWA2011-09-30
2179511050624810K103755TAPERLOC COMPLETE, SIZE 5 AND 6KWA2011-01-21
2179511905014615K103404ANA0TOMICAL SHOULDER TM COMBINED SYSTEMKWT2011-03-15
2179511349500551K101086TAPERLOC COMPLETEKWA2010-09-03
2179511273330401K090757BIOMET MODULAR FEMORAL REVISION SYSTEMKWA2009-09-25
2179511656914504K082996BIOLOX DELTA OPTION CERAMIC HEADSLZO2009-01-15
2179511743432591K062994LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTSKWA2007-03-09
2179511111676214K060692COMPREHENSIVE PRIMARY SHOULDER STEMSMBF2006-05-30
2179511253996541K052685ORTHOPEDIC SALVAGE SYSTEM- OSSKRO2005-10-27
2179512033467110K052089XR-SERIES BI-METRIC FEMORAL COMPONENTSLPH2006-02-17
2179511367050792K050441TAPER 2 POROUS FEMORAL STEMJDI2005-06-29
2179511767344011K023085RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEMJDI2002-10-17
2179511421288139K020580X-SERIES BI-METRIC HIP FEMORAL COMPONENTSLPH2002-03-22
2179511646483541K003429MALLOY/HEAD LATERALIZED PRESS-FIT FEMORALLPH2000-11-30
2179511158149065
2179511161887431
2179511188352200
2179511226166468
2179511276143954
2179511318670560
2179511356101220
2179511493381665
2179511738864305
2179511758259689
2179511767398459
2179511810189416
2179511824881993
2179511863973716
2179511942433708
2179512039803698
2179512045082888

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWA52011-09-30
LPH42012-08-17
JDI32005-06-29
MBH22016-05-10
JWH12017-07-28
PBI12012-11-23
KWT12011-03-15
LZO12009-01-15
MBF12006-05-30
KRO12005-10-27
HRS11989-10-06