FDA.reportPublic FDA data

Jim MacNee

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96153993002574147Jim MacNee1N2026-01-0131574 Flying Cloud Drive Laguna Niguel CA US 92677
96161283010138769Jim MacNee1N2026-01-0131574 Flying Cloud Drive Laguna Niguel CA US 92677
30041332293004133229Jim MacNee1N2026-01-0131574 Flying Cloud Drive Laguna Niguel CA US 92677
30063139793006313979Jim MacNee1N2026-01-0131574 Flying Cloud Drive Laguna Niguel CA US 92677
30106060973010606097Jim MacNee1N2026-01-0131574 Flying Cloud Dr Laguna Niguel CA US 92677
30041558323004155832Jim MacNee1N2020-04-2585 Plaza De Las Flores , San Juan Capis San Juan Capistrano CA US 92675
30113275013011327501Jim MacNee1N2020-04-2585 Plaza De Las Flores , San Juan Capis San Juan Capistrano CA US 92675

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
180001118795710K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)EBF2026-05-19
177651757048225K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)EBF2026-05-19
1921251390807130K243739AxCess® Expandable Interbody SystemMAX2025-01-24
180001423104160K231552Dia-CemEMA2023-07-28
177651523614406K231552Dia-CemEMA2023-07-28
180001474939890K220804Dia-X Bond UniversalKLE2022-06-15
177651568727008K220804Dia-X Bond UniversalKLE2022-06-15
180001300649189K210421Diafil & Diafil CapsuleEBF2021-06-28
177651648412279K210421Diafil & Diafil CapsuleEBF2021-06-28
180001497273003K210333DiaPasteKIF2021-03-25
177651784267475K210333DiaPasteKIF2021-03-25
177651155757321K200809D-LUX+EBZ2020-08-07
180001599079766K200809D-LUX+EBZ2020-08-07
177651233688969K200175DIA-ROOT BIO SealerKIF2020-06-25
180001432703143K200175DIA-ROOT BIO SealerKIF2020-06-25
180001428192650K200174DIA-ROOT BIO MTAKIF2020-09-18
177651633894197K200174DIA-ROOT BIO MTAKIF2020-09-18
177651080280154K192510DIAFIL & DIAFIL CapsuleEBF2020-03-20
180001890824330K192510DIAFIL & DIAFIL CapsuleEBF2020-03-20
180001032340459K192392DiaPlusKLE2020-05-26
177651797709536K192392DiaPlusKLE2020-05-26
177651375648068K192284DiaFil FlowEBF2020-03-25
180001916440942K192284DiaFil FlowEBF2020-03-25
177651032101204K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro KitKLE2020-02-07
180001361633576K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro KitKLE2020-02-07
180001003629889K192158DiaTempEBG2020-02-13
177651967301405K192158DiaTempEBG2020-02-13
180001132847132K192022DiaTemp FlowEBG2020-02-13
177651962400621K192022DiaTemp FlowEBG2020-02-13
180001580307120K190091DiapasteKIF2020-03-27
177651679071352K190091DiapasteKIF2020-03-27
180001241818456K182625Diapex PlusKIF2019-06-03
177651983541973K182625Diapex PlusKIF2019-06-03
177651186945588K182009Dia-ProsealKIF2019-09-26
180001450907726K182009Dia-ProsealKIF2019-09-26
2031141768096565K151592Gemmed pedicle screw spinal systemMNI2015-09-24
1921251475224537K142957Ideal pedicle screw spinal systemMNH2015-01-30
1921251348206283K141825IDEAL Locking Plate SystemHRS2015-03-03
1921252020603104K132428IDEALHSB2013-12-20
795151132846084K130312IROOT FMKIF2014-09-18
177651536161939K130163D-LUXEBZ2013-08-16
180001730534360K130163D-LUXEBZ2013-08-16
795151887927113K102867IROOT FSKIF2010-12-03
795151020012679K092715IROOT BP PLUSKIF2009-09-28
180001416293179K090992WELL-PASTEKIF2009-04-21
177651448110809K090992WELL-PASTEKIF2009-04-21
795151435579354K082943IROOT BP, MODEL IRBP 4609KIF2009-01-06
795151581618670K080917IROOT SPKIF2008-04-09
795151633456755K063422BIOAGGREGATEKIF2006-11-21
180001567686793K033585DIAPEXKIF2004-01-16
177651853481564K033585DIAPEXKIF2004-01-16
177651007586730
624091008611132
177651024561035
624091050190539
624091051574569
180001082806658
624091091025987
624091167596695
180001187013044
629301191269814
177651197568266
177651227651872
624091233033976
629301243699797
180001245034324
624091303344214
624091319134058
624091327092249
629301369031139
624091373605477
629301393891502
629301450593960
629301530818990
629301541183936
180001563851039
624091585236682
624091612556430
624091613081549
180001650902898
624091783028080
629301800974610
177651810780098
629301860626195
624091887115370
629301895265421
629301907890602
629302005365006
624092020339223
624092023748302
177651024263947
180001041583873
180001055847476
177651081359712
180001081783584
177651127409615
177651185026367
177651209262448
177651252757343
180001279525004
177651343834506
180001437036262
180001497668537
180001532504537
180001550656637
180001587537797
177651588560301
180001654536425
180001668554789
177651715139618
177651733894243
180001739811779
177651748478276
177651772274616
177651798758925

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KIF222021-03-25
EBF82026-05-19
KLE62022-06-15
EBZ42020-08-07
EBG42020-02-13
EMA22023-07-28
HRS22015-03-03
MNH22015-01-30
HSB22013-12-20
MAX12025-01-24
MNI12015-09-24