FDA.reportPublic FDA data

David Colao

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30009310343000931034David Colao1N2027-01-0110801 Nesbitt Avenue South Bloomington MN US 55437

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2922981815012218K994393AEQUALIS UNIVERSAL SHOULDER GLENOIDKWS2000-06-22
2922982025940209K994392AEQUALIS SHOULDER FRACTURE SYSTEMKWS2000-03-10
2922981452710078K994041TORNIER BIPOLAR RADIAL HEAD PROSTHESISKWI2000-08-31
2922981275820981K980244AEQUALIS SHOULDER PROSTHESISKWS1999-08-23
2922981065765862K973453TORNIER CEMENT RESTRICTORJDI1997-12-09
2922981381099311K952928AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONSKWS1995-09-27
2922981493146220K253674Blueprint Patient-Specific InstrumentationPHX2026-04-03
2922981640230755K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)PHX2026-01-08
2922981860090559K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidPHX2024-10-10
2922981713007035K232265BLUEPRINT™ Patient Specific InstrumentationPHX2024-02-21
2922981854973689K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationPHX2021-11-12
2922981253003347K190521Aequalis Ascend Flex Shoulder SystemKWS2019-06-12
2922981581867396K162800BLUEPRINT Patient Specific InstrumentationKWS2017-02-22
2922981931519231K161789BLUEPRINT Patient Specific InstrumentationKWS2016-12-27
2922981740312837K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
2922981180393385K160555BLUEPRINT Patient Specific InstrumentationKWS2016-06-10
2922981696456786K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisKWS2015-09-24
2922981247702283K143552Simpliciti Shoulder SystemPKC2015-03-04
2922981035926974K143374BLUEPRINT Patient Specific InstrumentationKWS2015-04-08
2922981473542730K140478AEQUALIS REVERSED SHOULDER PROSTHESISPHX2014-08-06
2922981734719630K140082AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEMPHX2014-07-18
2922981108402969K132285AEQUALIS REVERSED SHOULDER PROSTHESISPHX2013-12-05
2922981264632267K131231AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISPHX2013-10-16
2922981615666766K122698AEQUALIS ASCEND FLEX SHOULDER SYSTEMKWS2013-01-08
2922981831886419K112144AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESISPHX2012-03-13
2922981020390595K111902AEQUALIS SHOULDER SYSTEMKWS2011-11-03
2922981506870060K100142AEQUALIS REVERSED SHOULDER PROSTHESISPHX2010-05-06
2922981853771301K082120AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISKWS2008-10-24
2922981450090262K081059AEQUALIS REVERSED SHOULDER PROSTHESISPHX2008-07-17
2922981697209938K071948AEQUALIS REVERSED ADAPTERPHX2007-10-18
2922981654360205K061824TORNIER CEMENT RESTRICTORLZN2006-09-14
2922981653768571K061439AEQUALIS REVERSED PROSTHESISPHX2006-07-20
2922981748885292K060438RHSJDB2006-04-18
2922981996398655K060386NEXA CARPO METACARPAL IMPLANTKYI2006-05-10
2922981460999586K060209AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEMKWS2006-03-02
2922981261836076K050316AEQUALIS REVERSED SHOULDER PROSTHESISPHX2005-03-16
2922981393537684K041873AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-08-25
2922981770790956K041339AEQUALIS SHOULDER SYSTEMKWS2004-06-17
2922981200392552K030941AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-05-14
2922981819412059K012212MODIFICATION TO AEQUALIS SHOULDER SYSTEMKWS2001-08-15
2922981020492194K011942AEQUALIS PRESS-FIT SHOULDER PROSTHESISHSD2001-07-13
2922981118833509K001932TORNIER CEMENT RESTRICTORJDI2000-07-20
2922981611975443DEN220012Tornier Pyrocarbon Humeral HeadQKW2022-12-16
2922981010772957
2922981035153527
2922981060462491
2922981084981898
2922981101048395
2922981124900079
2922981154504975
2922981162148709
2922981194616089
2922981238364649
2922981303157043
2922981304884165
2922981306061146
2922981372096470
2922981402134835
2922981404948459
2922981406486892
2922981436574305
2922981459340439
2922981503847797
2922981569771303
2922981577976792
2922981630892575
2922981656613560
2922981656875114
2922981657669819
2922981682114195
2922981715998030
2922981722391169
2922981722612710
2922981730830736
2922981844583934
2922981860049516
2922981903852800
2922981960414692
2922981981062186
2922981985198736
2922982019300425
2922982046517753

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PHX182026-04-03
KWS162019-06-12
JDI22000-07-20
QKW12022-12-16
PKC12015-03-04
LZN12006-09-14
KYI12006-05-10
JDB12006-04-18
HSD12001-07-13
KWI12000-08-31