FDA.reportPublic FDA data

BIOMET UK LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028065353002806535BIOMET UK LTD.1N2026-01-01WATERTON INDUSTRIAL ESTATE BRIDGEND GB CF31 3XA

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1645581366094108P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
1645581995439744K833921AGC TOTAL KNEE PROSTHESISJWH1984-01-31
1645581238320651K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingLZO2020-07-29
1645581853811993K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsLZO2020-02-27
1645581614332425K150522G7 Dual Mobility SystemLPH2015-05-01
1645581777862216K142882G7 Freedom and Offset Liners, Freedom Head, Size 32LPH2015-02-10
1645581607255712K142746G7 Finned Acetabular ShellLPH2014-12-29
1645581901523452K141653BIOLOX DELTA CERAMIC OPTION HEADSLZO2014-08-18
1645581521909742K140669G7 OSSEOTI ACETUBLAR SHELLSLPH2014-12-11
1645581675400519K131684BIOLOX(R) DELTA CERAMIC HEADSLZO2013-10-10
1645581657174889K121874G7 ACETABULAR SYSTEMPBI2012-11-23
1645581127880768K120030TAPERLOC COMPLETE SIZE 4MM AND XR 123LPH2012-08-17
1645581591828942K110400TAPERLOC COMPLETE MICROPLASTY STEMKWA2011-09-30
1645581655424436K103755TAPERLOC COMPLETE, SIZE 5 AND 6KWA2011-01-21
1645581865113374K101086TAPERLOC COMPLETEKWA2010-09-03
1645581649281083K100469ARCOS INTERLOCKING DISTAL STEMSKWA2010-12-07
1645581167870464K09354944MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUMLZO2009-12-16
1645581244469860K093293VANGUARD 360 REVISION KNEE SYSTEMJWH2010-10-22
1645581169867466K082996BIOLOX DELTA OPTION CERAMIC HEADSLZO2009-01-15
1645581251878449K06131236MM BIOLOX DELTA CERAMIC HEADSLZO2006-06-06
1645581988555461K051411ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADSLZO2005-06-29
1645581008905633
1645581036000770
1645581185938023
1645581204863703
1645581255083793
1645581353095078
1645581594258261
1645581656682756
1645581680921155
1645581684967213
1645581699964372
1645581853939915
1645581887716488
1645581897182937
1645581938242207
1645582045841392
1645581033681190
1645581042886288
1645581420848131
1645581440533375
1645581581628234
1645581620162590
1645581718490790
1645581726208794
1645581850079694
1645581865537451

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZO82020-07-29
LPH52015-05-01
KWA42011-09-30
JWH22010-10-22
PBI12012-11-23
NRA12004-04-21

PMN#