FDA.reportPublic FDA data

TRIGON AMERICA LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30035964423003596442TRIGON AMERICA LLC1N2026-01-014000 Sussex Ave Aurora IL US 60504

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
597271438032657K980711HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATINGLPH1998-11-12
597271944408601K973412NATURAL-KNEE II CONSTRAINED KNEE SYSTEMJWH1997-12-08
597272018633879K953490TRILOGY ACETABULAR SHELL & LINERS 36MMLPH1995-10-20
597271273466644K934765TRILOGY ACETABULAR SYSTEMLPH1994-04-29
597271740975630K872019BI-ARTICULAR II HIP DEVICEKWY1987-07-21
597271948533224K833991BIPOLAR HIP DEVICEKWY1984-01-30
597271573842987K191625Persona Revision Knee SystemJWH2019-09-05
597271020231377K181947Persona Revision Knee SystemJWH2018-10-25
597271384423449K162024AltiVate Anatomic Shoulder SystemKWS2016-11-21
597272005337141K150600Response 5.5/6.0 Spine SystemNKB2015-05-22
597271828944418K143242Rebel 3DKNEE SystemJWH2015-05-15
597271947670883K122765PERSONA NATURAL TIBIA BASEPLATESJWH2012-11-09
597271276606755K120906ZIMMER TRABECULAR METAL TOTAL ANKLEHSN2012-08-24
597271264013424K113369ZIMMER PERSONA KNEE SYSTEMJWH2012-03-27
597271237160120K110959ORTHOPEDIATRICS BLADE PLATE SYSTEMHRS2011-08-05
597271049180710K110836CLS BREVIUS STEM WITH KINECTIV TECHNOLOGYKWA2011-10-07
597271066149667K103404ANA0TOMICAL SHOULDER TM COMBINED SYSTEMKWT2011-03-15
597271722464347K092234DYNESYS TOP-LOADING SPINAL SYSTEMNQP2009-10-01
597271034832666K083726PEDINAIL INTRAMEDULLARY NAILING SYSTEMHSB2009-03-11
597271706784738K052906ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEMPHX2005-12-19
597271661264814K031061NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTSMBH2003-10-09
597271548655190K021891ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEMLPH2002-09-05
597271301038155
597271422207847
597271024570674
597271043433315
597271148715135
597271221929330
597271249159457
597271343361705
597271372576291
597271399794998
597271431162573
597271452838892
597271586153062
597271724718209
597271733053196
597271740687925
597271745157348
597271872889618
597271884687128

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH62019-09-05
LPH42002-09-05
KWY21987-07-21
KWS12016-11-21
NKB12015-05-22
HSN12012-08-24
KWA12011-10-07
HRS12011-08-05
KWT12011-03-15
NQP12009-10-01
HSB12009-03-11
PHX12005-12-19
MBH12003-10-09