FDA.reportPublic FDA data

SHALBY ADVANCED TECHNOLOGIES, INC.

Matched from indexed company URL: Shalby Advanced Technologies

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30201550543020155054SHALBY ADVANCED TECHNOLOGIES, INC.1N2026-01-011115 Windfield Way El Dorado Hills CA US 95762

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
00840286841597Consensus Hip System/UniSyn Hip System - Slap Hammer, UniSyn+1(916)355-7100khansen@consensusortho.com
00840286841962Consensus Hip System - Impactor, One Piece Assembly, Consensus Stem+1(916)355-7100khansen@consensusortho.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2943891973649892K983004CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TIJWH1998-11-25
2943891391461896K964395PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENTLZO1997-01-27
2943891262356840K962215CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTERHWE1996-08-15
2943892035374370K960340CONSENSUS APEX DOME HOLE PLUGJDI1996-03-15
2943891254095509K960339CONSENSUS 22MM COCRMO FEMORAL HEADJDI1996-02-21
2943892065594222K960302CONSENSUS ACETABULAR SHELL, ALL UHMWPEJDI1996-04-01
2943891340681525K960156CONSENSUS 32MM COCRMO FEMORAL HEADJDI1996-02-21
2943891136743922K960151CONSENSUS 26MM COCRMO FEMORAL HEADJDI1996-02-21
2943891584479928K955386CONSENSUS ZIRCONIA FEMORAL HEADLZO1996-02-20
2943891910462328K954818CONSENSUS POSTERIOR STABILIZED KNEEJWH1996-05-22
2943891689820380K953792CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5LZO1995-11-06
2943891767223376K953443CONSENSUS PCL SUBSITUTING TIBIAL INSERTJWH1996-04-26
2943891437754650K952943CONSENSUS ALL POLY TIBIAJWH1996-04-01
2943891560837472K950013CONSENSUS(TM) ORTHOPEDIC DRILL BITHWE1995-05-05
2943891133734037K946197CONSENSUS(TM) PATELLA REAMERHWE1995-04-05
2943891883823884K945589CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATEJWH1995-05-31
2943891957608373K945208CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTERHWE1995-01-27
2943891833051783K945189CONSENSUS HIP SYSTEM -- CALCAR PLANERHWE1995-01-27
2943891949315965K945186CONSENUS HIP SYSTEM -- ACETABULAR REAMERHWE1995-01-27
2943891584928347K944946CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMERHWE1995-02-01
2943891234286412K935453CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEMMEH1994-07-13
2943891582570867K935193CONSENSUS HIP SYSTEM- POROUS COATED TITIANIUM FEMORAL STEMLZO1994-08-18
2943892073178216K933499CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEMLZO1994-05-18
2943892002072109K932837CONSENSUS KNEE SYSTEM - PRIMARY KNEEJWH1994-09-27
2943891588503761K922561CONSENSUS(TM) TOTAL HIP SYSTEMJDL1993-07-21
2943891584327106K922560CONSENSUS(TM) BIPOLAR SYSTEMKWY1992-09-11
2943891006906601K260796Tahoe Unicondylar Knee System with TiNbN OvercoatHSX2026-04-02
2943891971769816K241180Consensus Knee System with TiNbNJWH2025-01-14
2943891457859240K170344Tahoe Uni Knee SystemHSX2017-10-05
2943891838127891K160515PS2 Knee SystemJWH2016-12-19
2943891168039952K143725Consensus Knee System Modular Tibial BaseplateJWH2015-03-04
2943891996438701K141043CS2 MULTI-HOLE ACETABULAR SHELLLPH2014-05-19
2943891054903967K133919CONSENSUS VITALITE TIBIAL INSERTJWH2014-07-14
2943891673738100K130652VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERTOQG2013-12-17
2943891492059390K122512CS2 HIP SYSTEMLPH2012-11-05
2943891821117422K121935TAPERSET HIP SMALL STEMSLPH2012-09-10
2943891127961832K121636ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERTLPH2012-10-24
2943891406677257K121509TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERTKWY2012-11-05
2943891087666380K121263TAPER SET HIP SYSTEM RDP STEMLPH2012-05-22
2943891661477118K120595UNISYN PLUS HIP STEMLWJ2012-10-12
2943891577519395K112285MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE...JWH2011-11-04
2943891067797893K111472HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICONLPH2011-09-06
2943891545344938K110950CONSENSUS KNEE SYSTEMMBH2011-06-27
2943891545268555K110542CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEADLPH2011-04-01
2943891117672997K102927CONSENSUS KNEE SYSTEMMBH2011-01-26
2943891381240894K102399CONSENSUS TAPERSET HIP SYSTEMLPH2010-12-02
2943891523185747K100933CONSENSUS CS2 PLUS ACETABULAR INSERTLPH2010-10-06
2943891728603945K100542CONSENSUS REVISION KNEE SYSTEMJWH2010-06-24
2943891229250581K093089MAGNUM NAILHSB2009-11-13
2943891890431544K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTLWJ2007-01-31
2943891146538600K062383UNISYN HA PLASMA MODULAR HIPLWJ2006-12-21
2943891708091656K060635CONSENSUS ACETABULAR SHELL SYSTEMLPH2006-04-28
2943891734069618K030205CONSENSUS UNIPOLAR HEAD, COCRKWL2003-04-01
2943891192335162K030151CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEMLZO2003-04-10
2943891542155010K021466CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENELPH2002-07-24
2943892038113018K020153CONSENSUS ACETABLAR SHELL, TI COATEDLPH2002-04-15
2943891806725599K003649TRITON HIP SYSTEMLWJ2001-02-23
2943891825094422K001456CONSENSUS KNEE SYSTEMJWH2000-08-07
2943891018082160
2943891019937376
2943891222769475
2943891262501771
2943891282310850
2943891322475456
2943891335090731
2943891347354838
2943891350995555
2943891364599902
2943891410254104
2943891470284956
2943891581942361
2943891612193854
2943891621485121
2943891650774454
2943891651611177
2943891673784874
2943891684290730
2943891703048657
2943891706101815
2943891720293917
2943891803968982
2943891810328946
2943891824601307
2943891828396269
2943891876223343
2943891930153120
2943891942611980
2943892072880039

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH132025-01-14
LPH122014-05-19
HWE71996-08-15
LZO62003-04-10
JDI51996-04-01
LWJ42012-10-12
HSX22026-04-02
KWY22012-11-05
MBH22011-06-27
OQG12013-12-17
HSB12009-11-13
KWL12003-04-01
MEH11994-07-13
JDL11993-07-21

PMN#

GUDID#

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