FDA.reportPublic FDA data

OMNIlifeScience, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12261883008342029OMNIlifeScience, Inc.1Y2026-01-01480 Paramount Dr Raynham MA US 02767
12261883008342029OMNIlifeScience, Inc.1Y2020-04-25480 Paramount Dr Raynham MA US 02767

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3467962006698249K201611Apex Knee SystemJWH2021-04-02
3467961578907887K200888OMNIBotics Knee SystemOLO2020-06-27
562971722688169K191765OMNI TiN Coated Apex Knee™ SystemJWH2019-09-25
3467961989692478K191765OMNI TiN Coated Apex Knee™ SystemJWH2019-09-25
562971428294514K172467OMNI ARC Anteverted Neck Hip StemLZO2017-12-21
3467961482460415K172467OMNI ARC Anteverted Neck Hip StemLZO2017-12-21
3467961260480509K171156OMNI Anseris Hip StemLZO2017-08-17
562972046950312K171156OMNI Anseris Hip StemLZO2017-08-17
3467961659808503K163338OMNIBotics Knee SystemOLO2017-09-01
562971757401851K163338OMNIBotics Knee SystemOLO2017-09-01
562971472734281K163332Apex Revision Knee SystemJWH2017-04-26
3467961947783029K163332Apex Revision Knee SystemJWH2017-04-26
562971392122244K153437Apex Revision Knee SystemJWH2015-12-21
3467961889031781K153437Apex Revision Knee SystemJWH2015-12-21
3467961776868038K133381OMNI ARC MONOBLOCK HIP STEMLZO2014-03-13
562971963636240K133381OMNI ARC MONOBLOCK HIP STEMLZO2014-03-13
562971580852499K113242APEX ARC HIP STEMLPH2012-01-05
3467961995387321K113242APEX ARC HIP STEMLPH2012-01-05
3467961669300363K112891APEX REVISION KNEE SYSTEMSJWH2012-02-29
562971830786265K112891APEX REVISION KNEE SYSTEMSJWH2012-02-29
562971238468675K112779APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)LPH2011-12-02
3467961881021212K112779APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)LPH2011-12-02
562971345039215K111193APEX ARC HIP STEMLZO2011-06-27
3467961458115277K111193APEX ARC HIP STEMLZO2011-06-27
3467961276555934K111184APEX PS KNEE SYSTEM - PS-C INSERTJWH2011-06-22
562971378723382K111184APEX PS KNEE SYSTEM - PS-C INSERTJWH2011-06-22
562971030760852K111062APEX KNEE SYSTEM, APEX ALL POLY TIBIAJWH2011-07-13
3467961740979577K111062APEX KNEE SYSTEM, APEX ALL POLY TIBIAJWH2011-07-13
3467961514530258K110947APEX K1 HIP STEMLPH2011-06-16
562971989622796K110947APEX K1 HIP STEMLPH2011-06-16
562971262196116K102578APEX PS KNEE SYSTEMJWH2011-03-25
3467961808183969K102578APEX PS KNEE SYSTEMJWH2011-03-25
562971514190301K101994APEX KNEE MODULAR TIBIA SYSTEMJWH2010-09-28
3467962003861029K101994APEX KNEE MODULAR TIBIA SYSTEMJWH2010-09-28
562971248358361K101976INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSETLPH2010-09-14
3467961715334755K101976INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSETLPH2010-09-14
3467961191822689K101575APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010LPH2010-06-30
562971281173117K101575APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010LPH2010-06-30
562971652814016K101451APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEADLZO2010-06-22
3467961842626163K101451APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEADLZO2010-06-22
562971194741450K100555APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNKLPH2010-03-29
3467961786750200K100555APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNKLPH2010-03-29
562971526790222K100151APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)KWY2010-05-28
3467961616035882K100151APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)KWY2010-05-28
562971397702936K094017TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158JWH2010-03-05
3467961556522847K094017TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158JWH2010-03-05
3467961473475355K092443INTERFACE ACETABULAR CUP LINERSLPH2009-10-23
562971813687809K092443INTERFACE ACETABULAR CUP LINERSLPH2009-10-23
3467961844291946K090953TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCKOLO2010-01-21
562971897221550K090953TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCKOLO2010-01-21
562971259872877K090845APEX ARC HIP STEMLZO2010-04-07
3467961653184260K090845APEX ARC HIP STEMLZO2010-04-07
562971202167874K082468APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)KWY2009-02-18
3467962044125886K082468APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)KWY2009-02-18
3467961437400962K081232TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELESHAW2008-08-06
562971614681972K081232TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELESHAW2008-08-06
562971098282148K080842APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]MBH2008-05-23
3467961394065322K080842APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]MBH2008-05-23
3467961036872468K073602MODIFICATION TO: APEX KNEE SYSTEMJWH2008-02-14
562971891102529K073602MODIFICATION TO: APEX KNEE SYSTEMJWH2008-02-14
3467961574797588K073150APEX-LNK POLY ACETABULAR CUP LINERSLPH2008-02-27
562971776555453K073150APEX-LNK POLY ACETABULAR CUP LINERSLPH2008-02-27
562971578834483K072267TOTAL HIP SURGETICS NAVIGATION SYSTEMHAW2007-12-10
3467961926962216K072267TOTAL HIP SURGETICS NAVIGATION SYSTEMHAW2007-12-10
3467961331793390K063408CTLOGICS NAVIGATIONS SYSTEMSHAW2007-02-28
562971520801466K063408CTLOGICS NAVIGATIONS SYSTEMSHAW2007-02-28
562971784823098K062489APEX HCLA ACETABULAR CUP LINERSLPH2007-08-15
3467962072999660K062489APEX HCLA ACETABULAR CUP LINERSLPH2007-08-15
562971651179440K062146UNI KNEE SURGETICS NAVIGATION SYSTEMHAW2006-08-21
3467961689460250K062146UNI KNEE SURGETICS NAVIGATION SYSTEMHAW2006-08-21
3467961635621174K060282TOTAL KNEE SURGETICS NAVIGATION SYSTEMHAW2006-04-10
562971805908445K060282TOTAL KNEE SURGETICS NAVIGATION SYSTEMHAW2006-04-10
562971384884910K060192APEX KNEE SYSTEMJWH2006-06-15
3467961557409846K060192APEX KNEE SYSTEMJWH2006-06-15
562971145139334K060072MONOBLOCK PRESS-FIT HIP STEMLPH2006-08-24
3467961952456086K060072MONOBLOCK PRESS-FIT HIP STEMLPH2006-08-24
562971210928450K053542SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEMHAW2006-04-10
3467961443595703K053542SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEMHAW2006-04-10
562971200333543K043123APEX MODULAR HA HIP STEMLPH2005-02-10
3467962058839153K043123APEX MODULAR HA HIP STEMLPH2005-02-10
562971714069368K041950APEX K2 HIP SYSTEMLPH2004-12-21
3467961786426245K041950APEX K2 HIP SYSTEMLPH2004-12-21
3467961234216409K040224CADIMPLANTJAK2004-04-06
562971603581991K040224CADIMPLANTJAK2004-04-06
562971770161770K031196SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEMHAW2005-06-07
3467962007419161K031196SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEMHAW2005-06-07
3467961016342136K031110APEX MODULAR ACETABULAR CUPLPH2003-05-22
562971060137393K031110APEX MODULAR ACETABULAR CUPLPH2003-05-22
562971485026014K022239SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEMJAK2002-08-23
3467961699148652K022239SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEMJAK2002-08-23
3467961236960686K012918APEX MODULAR ALUMINA FEMORAL HEADLZO2001-11-27
562971427769720K012918APEX MODULAR ALUMINA FEMORAL HEADLZO2001-11-27
3467961157701646K003923APEX MODULAR ZIRCONIA FEMORAL HEADLZO2001-03-20
562971178285610K003923APEX MODULAR ZIRCONIA FEMORAL HEADLZO2001-03-20
562971728946556K000788APEX MODULAR HIP STEMLPH2000-08-04
3467961951118106K000788APEX MODULAR HIP STEMLPH2000-08-04
562971069314789
562971126631766
562971138018798
562971328518866
562971344792997
562971346030484
562971448777959
562971465707979
562971473514773
562971481599825
562971486118254
562971600094451
562971637285629
562971674564180
562971762006834
562971767102536
562971767523122
562971818958722
562971960647447
562972007878038
562972047208353

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LPH282012-01-05
JWH232021-04-02
LZO162017-12-21
HAW142008-08-06
OLO52020-06-27
KWY42010-05-28
JAK42004-04-06
MBH22008-05-23