FDA.reportPublic FDA data

Viant AS&O Holdings, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12188821218882Viant AS&O Holdings, LLC1N2026-01-0168 MILL LN. RD. Brimfield MA US 01010
12214851221485Viant AS&O Holdings, LLC1N2026-01-0145 Lexington Dr LACONIA NH US 03246
13194291000120314Viant AS&O Holdings, LLC1N2026-01-013902 CALIFORNIA RD. ORCHARD PARK NY US 14127
18322281832228Viant AS&O Holdings, LLC1N2026-01-013735 NORTH ARLINGTON AVE. Indianapolis IN US 46218

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2252281973096991K993801GYNECARE LAPAROSCOPIC MORCELLATORHET2000-02-07
2253151097515642K972138CARR RIGID CONTAINER SYSTEMFRG1997-11-13
2252501372375409K844373O.M.S. ULTRA-PHACOHQC1985-12-19
2252501068232080K840695PHACOEMULSIFICATION KITSHQC1984-05-22
2253151225398683K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADLZO2016-11-01
2253151500462487K152494Zimmer NexGen Complete Knee Solution Tibial and Femoral AugmentsJWH2015-11-25
2253151140309505K150600Response 5.5/6.0 Spine SystemNKB2015-05-22
2253151562519205K150090Zimmer Persona Personalized Knee SystemMBH2015-05-20
2253151101439902K141370RENOVIS CEMENTED HIP SYSTEMJDI2014-09-02
2252281465151477K141122HARMONIC SCALLOP BLADE, GENERATOR G11GEI2014-09-15
2253151033457367K140431PEDILOC FRAGMENT SYSTEMHRS2014-07-29
2253151350107047K131122S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMOVD2013-09-18
2253151468265555K130655RESPONSE SPINE SYSTEMOSH2013-05-08
2253152025670363K130217ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEMMBI2013-06-20
2252281631554477K122797ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAWGEI2013-01-25
2253151180631540K121904GYNECOLOGY STERILIZATION TRAYKCT2013-03-11
2253151029628675K120906ZIMMER TRABECULAR METAL TOTAL ANKLEHSN2012-08-24
2253151785173570K120038A200 KNEE SYSTEMOIY2013-02-14
2253151525679186K113296ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMERLPH2012-09-14
2253151438661241K113084RENOVIS CANNULATED SCREW SYSTEMHWC2011-12-09
2253151268235807K112897RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESISOQG2012-06-13
2252281165718329K112892IMPELLA 2.5 PLUS CATHETERPBL2012-09-06
2253151395097233K111086ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEMHRS2011-06-17
2253151041305950K110959ORTHOPEDIATRICS BLADE PLATE SYSTEMHRS2011-08-05
2252281196148293K102983VASCUCLEAR PRECISION BIPOLARGEI2010-11-01
2253151706195117K100240ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEMHRS2010-05-17
2252281675115207K093236ETHICON ENDO-SURGERYOPTICAL DILATORKNQ2009-11-10
2253151670988646K090666PEDIPLATESHRS2009-04-24
2253152062980630K083726PEDINAIL INTRAMEDULLARY NAILING SYSTEMHSB2009-03-11
2253151612368837K083286ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEMHRS2009-01-30
2253151150043475K082375ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEMHTY2008-10-17
2253151382544294K081407ORTHOPEDIATRICS PEDIPLATES SYSTEMHRS2008-07-22
2253151131180849K052906ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEMPHX2005-12-19
2252281854324684K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626DWS2002-10-09
2252281533969224K003286SYMPHONY GRAFT DELIVERY SYSTEMLYC2001-01-18
2253151143242709
2253151146033325
2253151180217464
2253151326761093
2253151357644662
2253151454684697
2253151750228208
2253151988566595
2252171002275629
2252171003871261
2252171020694047
2253151024648434
2252281049797247
2252281085257959
2252281095402675
2253151097515642
2252281101806165
2252171105762075
2252171124706797
2252281130398862
2252281139360406
2253151140068395
2252171143242709
2252501143934943
2252171146033325
2252501178636948
2253151180631540
2252501194384086
2252501205203260
2252501206236225
2253151233310186
2252501233719164
2252281235004128
2252171254757127
2252171262702041
2252171266302042
2252171269183348
2252171296700592
2252171307361617
2253151319633669
2252171326526213
2252281339586901
2252501346894026
2252171356795834
2252501360807655
2252501382655504
2252281391573814
2252171396103247
2252281409462591
2252281422331475
2253151431663141
2252281442529346
2252501446290637
2252171454684697
2252281474661795
2252171474711271
2252171487167138
2252171498226850
2252281516858286
2252281532975747
2252501537182554
2252281548686266
2252171550762662
2252501577639591
2252281591670705
2252281622540295
2252281625405824
2252281638164949
2252171652969871
2252281659762067
2252281750582827
2252501764289894
2253151814772106
2253151819084671
2253151823199512
2252281828147583
2252281841484622
2252501859139744
2252171870696192
2252171888470188
2252171901589081
2252281929551358
2252501930089067
2252171945064595

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS72014-07-29
GEI32014-09-15
HQC21985-12-19
LZO12016-11-01
JWH12015-11-25
NKB12015-05-22
MBH12015-05-20
JDI12014-09-02
OVD12013-09-18
MBI12013-06-20
OSH12013-05-08
KCT12013-03-11
OIY12013-02-14
LPH12012-09-14
PBL12012-09-06
HSN12012-08-24
OQG12012-06-13
HWC12011-12-09
KNQ12009-11-10
HSB12009-03-11
HTY12008-10-17
PHX12005-12-19
DWS12002-10-09
LYC12001-01-18
HET12000-02-07
FRG11997-11-13