FDA.reportPublic FDA data

ORTHO DEVELOPMENT CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
17225111000143502ORTHO DEVELOPMENT CORP.1N2026-01-0112187 SOUTH BUSINESS PARK DR. DRAPER UT US 84020

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
504301127110763K994370ORTHO DEVELOPMENT BALANCED KNEE SYSTEMJWH2000-03-24
504301563859401K990986CONTOUR SPINAL SYSTEMKWP1999-10-14
504301436958723K982389ODC B2 BIPOLAR CUPKWY1998-10-07
504301135165855K971435HEADLOC CERAMIC FEMORAL HEADSLZO1997-07-09
504301230379591K971426HEADLOC CERAMIC HEADLZO1997-07-09
504301808030916K970675HEADLOC CERAMIC HEADLZO1997-08-22
504301468223597K962448PRIMALOC CEMENTED HIP SYSTEMKWY1996-09-19
504301525951804K960660HEMISPHERE ACETABULAR CUPLPH1996-05-08
504302058394216K953977PRIMALOC CEMENTLESS HIP SYSTEMKWY1996-01-26
504301525561367K913708VENUS HIPLWJ1992-01-27
504301715229321K253161Balanced Knee System TriMax Porous Femoral ComponentsMBH2025-12-19
504301166108323K251052Trivicta® Hip StemMEH2025-05-22
504301548943612K242984BKS Revision SystemJWH2024-10-25
504301592466216K242833Legend® Acetabular ShellLPH2024-10-11
504301775928177K233758Trivicta™ Hip StemMEH2024-03-08
504301189618251K233093Balanced Knee® System TriMax PS Plus Tibial InsertJWH2023-10-25
504301656435998K211471Balanced Knee System UniHSX2021-12-16
504301892658304K211086The Progen™ Trochanteric Nail SystemHSB2021-12-21
504301205744088K203023Pisces Spinal SystemNKB2021-07-14
504301271465536K200281The Gecko Spinal SystemOWI2020-03-31
504301168539167K182085Balanced Knee Revision System Trabecular Tibial Cone AugmentsJWH2018-10-31
504301030111398K181569BKS Revision Sleeves SystemJWH2018-10-12
504301152500146K180743Balanced Knee Revision System - Offset Junction BoxJWH2018-06-20
504301141616601K173951Legend Acetabular LinersLPH2018-05-30
504301306440719K171249Entrada™ hip stemMEH2017-08-24
504301159828917K162995Ibis® Pedicle Screw SystemNKB2017-03-30
504301603801641K161080Escalade Legend Acetabular ShellLPH2016-05-17
504301725210310K153216Alpine Cemented Hip SystemJDI2016-02-18
504301356620531K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsJWH2015-10-27
504301735491858K142146IBIS PEDICLE SCREW SYSTEMNKB2014-12-11
504301060370307K141001ALPINE HIP STEM; ALPINE HA HIP STEMLPH2014-07-30
504301506985532K133449KASM KNEE ARTICULATING SPACER MOLDSJWH2014-02-18
504301045507667K133386OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEMLPH2014-03-11
504301460675455K132697ENCOMPASS 10/12 HIP STEMLPH2014-06-20
504301737989750K131785PAGODA PEDICLE SCREW SYSTEMNKB2013-08-20
504301338275092K131337BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLAJWH2013-10-11
504301875625906K131022OVATION 10/12 HIP STEMLPH2013-10-16
504301312951350K123457BALANCED KNEE SYSTEM HIGH FLEX PSJWH2013-03-22
504301832379904K122588VUSION CS PLUSODP2013-06-12
504301883254494K111965VUSION(R) OSMAX2011-10-25
504301014850507K111936ORTHO DEVLOPMENT CERAMIC FEMORAL HEADLZO2011-09-21
504301115259603K103837BALANCED KNEE SYSTEM REVISION OFFSET TIBIAJWH2011-03-24
504301829508634K103384ESCALADE ACETABULAR CUP SYSTEMLPH2011-03-16
504301909603437K090705BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERTJWH2009-10-09
504302072758094K062775EUROPEAN STYLE TAPER,PRESS-FIT HIP STEMLPH2007-01-16
504301670929609K062666VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTSMQP2007-01-25
504301974066696K061524ISS INTEGRATED SPINE SYSTEMMNH2006-09-26
504301622374396K060577ORTHO DEVELOPMENT CERAMIC FEMORAL HEADSLZO2006-04-28
504301020436189K060569BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEMJWH2006-07-06
504301838538843K053587ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMSLZO2006-03-17
504301875746154K053293ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMSLPH2006-02-16
504301187077379K051407LEGEND ALL-POLY CUPJDI2005-09-08
504301054405048K050966PIVOT BIPOLAR FEMORAL HEADKWY2005-07-07
504301255766360K050637ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADSJDI2005-09-23
504301656363416K042973SOLITUDE UNIPOLAR HEADKWL2005-01-27
504301081275435K042565ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINERLPH2005-04-11
504301137747214K031201ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEMJWH2003-07-15
504301783776897K020649ENVISION ANTERIOR CERVICAL PLATE SYSTEMKWQ2002-04-05
504301315148499K020383ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGEDJWH2002-05-06
504301742959677K000321HEMISPHERE MODULAR CUP SYSTEMLPH2000-04-10
504301025505429
504301033759388
504301066430253
504301069540142
504301120568611
504301134756064
504301142283245
504301143762904
504301150597435
504301184013603
504301190483475
504301311298478
504301354778434
504301438591950
504301492047846
504301532741452
504301575381613
504301596923150
504301640543021
504301714288987
504301722544801
504301738776179
504301747927096
504301814364272
504301822414260
504301828648123
504301837737047
504301893556473
504301929240749
504301980288842
504301990043561

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH152024-10-25
LPH132024-10-11
LZO62011-09-21
NKB42021-07-14
KWY42005-07-07
MEH32025-05-22
JDI32016-02-18
MBH12025-12-19
HSB12021-12-21
HSX12021-12-16
OWI12020-03-31
ODP12013-06-12
MAX12011-10-25
MQP12007-01-25
MNH12006-09-26
KWL12005-01-27
KWQ12002-04-05
KWP11999-10-14
LWJ11992-01-27

PMN#

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