FDA.reportPublic FDA data

UNITED ORTHOPEDIC CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96816421000395711UNITED ORTHOPEDIC CORP.1N2026-01-01No. 16, Luke 1st Rd. Luzhu Dist., Kaohsiung TW 82151

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
04719886896466United Hip System - Momentum E-XPE Mobile Bearing, ID22mm, Fits OD42mm Shell+886229294567tw.service@unitedorthopedic.com
04719886896473United Hip System - Momentum E-XPE Mobile Bearing, ID22mm, Fits OD44mm Shell+886229294567tw.service@unitedorthopedic.com
04719886896480United Hip System - Momentum E-XPE Mobile Bearing, ID22mm, Fits OD48mm Shell+886229294567tw.service@unitedorthopedic.com
04719886896497United Hip System - Momentum E-XPE Mobile Bearing, ID22mm, Fits OD52mm Shell+886229294567tw.service@unitedorthopedic.com
04719886896503United Hip System - Momentum E-XPE Mobile Bearing, ID22mm, Fits OD54~56mm Shells+886229294567tw.service@unitedorthopedic.com
04719886896510United Hip System - Momentum E-XPE Mobile Bearing, ID22mm, Fits OD58~60mm Shells+886229294567tw.service@unitedorthopedic.com
04719886896527United Hip System - Momentum E-XPE Mobile Bearing, ID22mm, Fits OD62~64mm Shells+886229294567tw.service@unitedorthopedic.com
04719886896534United Hip System - Momentum E-XPE Mobile Bearing, ID22mm, Fits OD66~70mm Shells+886229294567tw.service@unitedorthopedic.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
164291988295417K994078U1 HIP SYSTEMLPH2000-12-04
164291051536215K973854ORION ANTERIOR CERVICAL PLATE SYSTEMKWQ1998-03-16
164291400149407K253948Momentum Acetabular Cup SystemLZO2026-09-02
164291497405724K252725Stem Extension Line (U2 Total Knee System—PSA Type)JWH2025-09-25
164291483032710K252303Stem Extension Line (USTAR II System)KRO2025-08-22
164291805971512K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaMBH2025-07-31
164291574124359K243466Conformity Stem Extension Line, #0LZO2025-01-06
164292048890347K243024Cellbrick Knee SpacerJWH2024-12-20
164291406830160K242315Resolve Modular Revision Hip StemMEH2025-05-01
164291933049544K242249Conformity Stem Extension LineLZO2024-08-30
164291100522714K222700Tibial baseplate, Tibial insertJWH2022-10-06
164291681790615K221705U2 Total Knee System-PF+MBH2023-02-28
164291778287895K221675United U2 femoral head, 22mm delta ceramic headLPH2022-11-04
164291888200903K221149U-Motion II Acetabular System-Extension lineLZO2023-01-05
164291837298604K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSJWH2021-04-21
164291399634057K191056Conformity stem, cementedJDI2020-01-03
164291761236716K190100USTAR II SystemKRO2019-09-23
164292013733394K183312Conformity StemLZO2019-08-08
164291203045663K172833E-XPE Acetabular Components and U-Motion II Acetabular CupOQI2018-06-12
164291524725915K172251UTS StemLPH2017-10-24
164291106646877K170089U-Motion II Acetabular System— Additional sizesLZO2017-10-06
164291179331573K163441Locking Cage, Full XPE CupLZO2017-08-25
164291255575622K163193UTF Stem, reduced, #0, #00LPH2017-06-08
164292050226791K162957U2 Femoral HeadLPH2017-07-17
164291230832577K161705U2 Total Knee System E-XPE productsJWH2017-03-16
164292031604696K161360U2 Total Knee System, PSA Tibial InsertJWH2017-02-01
164291711622049K152530UCP StemLZO2016-03-14
164291295280521K152439U2 Bipolar Implant and 22mm Femoral HeadKWY2016-04-07
164291379738981K152430All Poly Tibial ComponentJWH2016-04-12
164291730540811K151316U2 Hip Stem, Ti Porous Coated, MatrixLPH2015-08-13
164291940618123K150832U2 Femoral Component, CR, Porous Coated, Additional SizesMBH2015-09-25
164291008384636K150829U2 Total Knee System- Additional SizesJWH2015-09-25
164291865399487K140075U2 FEMORAL COMPONENT, CR, POROUS COATEDMBH2014-06-13
164291275029887K140073U2 FEMORAL COMPONENT, CR, CEMENTEDJWH2014-06-16
164291512793596K132752ULTRACONGRUENT INSERTJWH2014-03-13
164291005708096K132455U-MOTION II PS+ CUPLZO2013-09-03
164291234981047K132207UTF STEM-REDUCED, ADDITIONAL SIZESLPH2013-08-30
164291019799563K131864U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENTJWH2014-01-15
164291880752535K131116U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTERJWH2013-10-30
164291604565804K123550UTF STEM, REDUCEDLPH2013-05-01
164291930436064K122504FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTHLPH2012-10-10
164291281341913K122185U-MOTION II ACETABULAR SYSTEMLZO2013-02-22
164291172692436K122183AUGMENT AND SCREW, PSA TYPEJWH2013-02-05
164291053087513K121777U2 ACETABULAR CUP, PLASMA SPRAYLPH2012-07-18
164292059035885K120507UNITED U2 FEMORAL COMPONENT, PS, #7JWH2012-05-04
164291253835711K112463UNITED 36MM CERAMIC FEMORAL HEAD, DELTALZO2011-09-23
164291682108322K111546U2 HIP SYSTEMLPH2011-07-01
164291753675326K110245UNITED UTF STEMLPH2011-08-04
164291114014710K103733UNITED U2 XPE TOTAL KNEE SYSTEMJWH2011-08-02
164291587996081K103497CERAMIC FEMORAL HEADMEH2011-03-04
164291893448810K101670UNITED U2 BIPOLAR IMPLANTKWY2010-10-08
164291929663041K100981UNITED STEM, PSA TYPEJWH2010-06-14
164292008299280K082469UNITED U2 PATELLAJWH2008-09-26
164291247733926K082424UNITED U2 TOTAL KNEE SYSTEMJWH2008-12-16
164292040710747K062978U2 HIP STEM, TI PLASMA SPRAYLWJ2007-01-16
164291252564771K051640U2 TOTAL KNEE SYSTEMJWH2006-03-01
164291547284720K051039BASIS SPINAL SYSTEMKWQ2005-05-12
164291592649207K050269U1 HIP SYSTEM - BIPOLARKWY2005-08-29
164292055616027K050262U2 ACETABULAR COMPONENTLWJ2005-08-15
164291852885716K022520U2 ACETABULAR CUPLPH2003-02-25
164291460326489K021657UKNEE TOTAL KNEE SYSTEMJWH2002-08-12
164291951414491K003237U2 HIP STEM, TI POROUS COATEDLPH2001-01-10
164291669436303
164291008806231
164291070764739
164291163754566
164291213305879
164291339403251
164291402982716
164291424615933
164291457272935
164291485628018
164291510010925
164291523890293
164291642888146
164291664517292
164291678124579
164291694738844
164291722978316
164291746484829
164291770188742
164291860338736
164291944185197
164292005723924
164292014199920
164292057425513

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
KWQ22005-05-12
JDI12020-01-03
OQI12018-06-12

PMN#

GUDID#

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