FDA.reportPublic FDA data

UNITED ORTHOPEDIC CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30123299263012329926UNITED ORTHOPEDIC CORPORATION1N2026-01-0157 Park Ave. 2, Science Park Hsinchu Hsinchu(County) TW TW NOTA300

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3462401678124579K994122BONE GRAFT WASHER, MODEL 9090114 - 9090118KWQ2000-02-18
3462401988295417K994078U1 HIP SYSTEMLPH2000-12-04
3462401860338736K991528MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTORMNH1999-05-28
3462401424615933K982490TENOR SPINAL SYSTEMKWP1998-10-05
3462401746484829K970806ACPII ANTERIOR CERVICAL PLATE SYSTEMKWQ1997-05-02
3462401008806231K924085RECONSTRUCTION PLATE SYSTEMHRS1992-12-17
3462401400149407K253948Momentum Acetabular Cup SystemLZO2026-09-02
3462401497405724K252725Stem Extension Line (U2 Total Knee System—PSA Type)JWH2025-09-25
3462401483032710K252303Stem Extension Line (USTAR II System)KRO2025-08-22
3462401805971512K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaMBH2025-07-31
3462401574124359K243466Conformity Stem Extension Line, #0LZO2025-01-06
3462402048890347K243024Cellbrick Knee SpacerJWH2024-12-20
3462401406830160K242315Resolve Modular Revision Hip StemMEH2025-05-01
3462401933049544K242249Conformity Stem Extension LineLZO2024-08-30
3462401100522714K222700Tibial baseplate, Tibial insertJWH2022-10-06
3462401681790615K221705U2 Total Knee System-PF+MBH2023-02-28
3462401778287895K221675United U2 femoral head, 22mm delta ceramic headLPH2022-11-04
3462401888200903K221149U-Motion II Acetabular System-Extension lineLZO2023-01-05
3462401837298604K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSJWH2021-04-21
3462401399634057K191056Conformity stem, cementedJDI2020-01-03
3462401761236716K190100USTAR II SystemKRO2019-09-23
3462402013733394K183312Conformity StemLZO2019-08-08
3462401203045663K172833E-XPE Acetabular Components and U-Motion II Acetabular CupOQI2018-06-12
3462401524725915K172251UTS StemLPH2017-10-24
3462401106646877K170089U-Motion II Acetabular System— Additional sizesLZO2017-10-06
3462401179331573K163441Locking Cage, Full XPE CupLZO2017-08-25
3462401255575622K163193UTF Stem, reduced, #0, #00LPH2017-06-08
3462402050226791K162957U2 Femoral HeadLPH2017-07-17
3462401230832577K161705U2 Total Knee System E-XPE productsJWH2017-03-16
3462402031604696K161360U2 Total Knee System, PSA Tibial InsertJWH2017-02-01
3462401711622049K152530UCP StemLZO2016-03-14
3462401295280521K152439U2 Bipolar Implant and 22mm Femoral HeadKWY2016-04-07
3462401379738981K152430All Poly Tibial ComponentJWH2016-04-12
3462401730540811K151316U2 Hip Stem, Ti Porous Coated, MatrixLPH2015-08-13
3462401940618123K150832U2 Femoral Component, CR, Porous Coated, Additional SizesMBH2015-09-25
3462401008384636K150829U2 Total Knee System- Additional SizesJWH2015-09-25
3462401865399487K140075U2 FEMORAL COMPONENT, CR, POROUS COATEDMBH2014-06-13
3462401275029887K140073U2 FEMORAL COMPONENT, CR, CEMENTEDJWH2014-06-16
3462401512793596K132752ULTRACONGRUENT INSERTJWH2014-03-13
3462401005708096K132455U-MOTION II PS+ CUPLZO2013-09-03
3462401234981047K132207UTF STEM-REDUCED, ADDITIONAL SIZESLPH2013-08-30
3462401019799563K131864U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENTJWH2014-01-15
3462401880752535K131116U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTERJWH2013-10-30
3462401604565804K123550UTF STEM, REDUCEDLPH2013-05-01
3462401930436064K122504FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTHLPH2012-10-10
3462401281341913K122185U-MOTION II ACETABULAR SYSTEMLZO2013-02-22
3462401172692436K122183AUGMENT AND SCREW, PSA TYPEJWH2013-02-05
3462401053087513K121777U2 ACETABULAR CUP, PLASMA SPRAYLPH2012-07-18
3462402059035885K120507UNITED U2 FEMORAL COMPONENT, PS, #7JWH2012-05-04
3462401253835711K112463UNITED 36MM CERAMIC FEMORAL HEAD, DELTALZO2011-09-23
3462401682108322K111546U2 HIP SYSTEMLPH2011-07-01
3462401753675326K110245UNITED UTF STEMLPH2011-08-04
3462401114014710K103733UNITED U2 XPE TOTAL KNEE SYSTEMJWH2011-08-02
3462401587996081K103497CERAMIC FEMORAL HEADMEH2011-03-04
3462401893448810K101670UNITED U2 BIPOLAR IMPLANTKWY2010-10-08
3462401929663041K100981UNITED STEM, PSA TYPEJWH2010-06-14
3462402008299280K082469UNITED U2 PATELLAJWH2008-09-26
3462401247733926K082424UNITED U2 TOTAL KNEE SYSTEMJWH2008-12-16
3462402040710747K062978U2 HIP STEM, TI PLASMA SPRAYLWJ2007-01-16
3462401252564771K051640U2 TOTAL KNEE SYSTEMJWH2006-03-01
3462401592649207K050269U1 HIP SYSTEM - BIPOLARKWY2005-08-29
3462402055616027K050262U2 ACETABULAR COMPONENTLWJ2005-08-15
3462402005723924K042498VERTEX RECONSTRUCTION SYSTEMKWP2004-10-07
3462401523890293K042453MODIFICATION TO EQUATION FIXATION SYSTEMMNI2004-10-07
3462401510010925K032037CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)MNI2003-09-04
3462401852885716K022520U2 ACETABULAR CUPLPH2003-02-25
3462401460326489K021657UKNEE TOTAL KNEE SYSTEMJWH2002-08-12
3462401213305879K010930LIFT VB SPINAL SYSTEMMQP2001-10-24
3462401951414491K003237U2 HIP STEM, TI POROUS COATEDLPH2001-01-10
3462401070764739
3462401163754566
3462401339403251
3462401402982716
3462401457272935
3462401485628018
3462401642888146
3462401664517292
3462401694738844
3462401722978316
3462401770188742
3462401944185197
3462402014199920
3462402057425513

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH202025-09-25
LPH142022-11-04
LZO112026-09-02
MBH42025-07-31
KWY32016-04-07
KRO22025-08-22
MEH22025-05-01
LWJ22007-01-16
KWP22004-10-07
MNI22004-10-07
KWQ22000-02-18
JDI12020-01-03
OQI12018-06-12
MQP12001-10-24
MNH11999-05-28
HRS11992-12-17

PMN#