FDA.reportPublic FDA data

Kevin Smith

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30083378083008337808Kevin Smith1N2020-04-2510801 Nesbitt Ave S Bloomington MN US 55437

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1091581061226856K994393AEQUALIS UNIVERSAL SHOULDER GLENOIDKWS2000-06-22
1091581469190510K994392AEQUALIS SHOULDER FRACTURE SYSTEMKWS2000-03-10
1091581033114467K952928AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONSKWS1995-09-27
1091581047386779K190521Aequalis Ascend Flex Shoulder SystemKWS2019-06-12
1091581925049336K182461LATITUDE EV Total Elbow ArthroplastyJDB2018-12-27
1091581181720471K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
1091581473021302K160975Aequalis PerFORM+ Shoulder SystemKWS2016-06-10
1091581272424469K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS2015-09-24
1091581824752099K143552Simpliciti Shoulder SystemPKC2015-03-04
1091581524044484K140478AEQUALIS REVERSED SHOULDER PROSTHESISPHX2014-08-06
1091581030566020K140082AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEMPHX2014-07-18
1091581041236334K132285AEQUALIS REVERSED SHOULDER PROSTHESISPHX2013-12-05
1091581106949377K131231AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISPHX2013-10-16
1091582036149715K122698AEQUALIS ASCEND FLEX SHOULDER SYSTEMKWS2013-01-08
1091581900215208K121425ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEMHRS2012-10-01
1091581917300409K120802ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWSHRS2012-04-02
1091581006804446K120794ASCEND SHOULDER SYSTEMKWS2012-04-13
1091581215427691K120359ORTHOLOC 3DI HALLUX SYSTEMHRS2012-05-03
1091581304247277K113413ASCEND SHOULDER SYSTEMKWS2012-03-09
1091581807882406K111902AEQUALIS SHOULDER SYSTEMKWS2011-11-03
1091581503197311K102429ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREWHRS2010-11-23
1091581694592380K082120AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISKWS2008-10-24
1091581251398265K081059AEQUALIS REVERSED SHOULDER PROSTHESISPHX2008-07-17
1091581117509616K071147NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEMKWT2007-07-20
1091581220435056K063081AEQUALIS SHOULDER SYSTEMHSD2006-11-09
1091581498986169K061824TORNIER CEMENT RESTRICTORLZN2006-09-14
1091581918370485K061439AEQUALIS REVERSED PROSTHESISPHX2006-07-20
1091582014495433K060988TOTAL AND HEMI SHOULDER SYSTEMKWS2006-12-06
1091581099192372K060209AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEMKWS2006-03-02
1091581619753364K050316AEQUALIS REVERSED SHOULDER PROSTHESISPHX2005-03-16
1091581963939805K041873AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-08-25
1091581624799770K041339AEQUALIS SHOULDER SYSTEMKWS2004-06-17
1091581971342802K030941AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-05-14
1091581173684473
1091581321083423

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWS142019-06-12
PHX102016-11-15
HRS42012-10-01
JDB12018-12-27
PKC12015-03-04
KWT12007-07-20
HSD12006-11-09
LZN12006-09-14