FDA.reportPublic FDA data

Arthrex Logistic Center

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30094231123009423112Arthrex Logistic Center1Y2026-01-0114550 Plantation Road Fort Myers FL US 33912

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1388121201265194K961228KARL STORZ MAGNIFYING ARTHROSOCPESHRX1996-10-10
1388121370672514K943492ARTHREX STAPLESJDR1995-02-01
1388121508377083K943154KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHSHRX1994-12-06
1388122059197007K170382Arthrex Compression ScrewsHWC2017-05-11
1388121821486538K151527Arthrex Univers Revers CA Heads and AdaptersHSD2016-04-19
1388121772694788K142863Univers Rivers Shoulder Prosthesis SystemPHX2014-11-25
1388121732533838K132217ARTHREX COMPRESSION FT SCREWSHWC2013-11-25
1388121176882465K131474ARTHREX DISTAL RADIUS PLATE SYSTEMHRS2013-07-03
1388121940918789K123341ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTONMBI2012-12-21
1388121547827721K122374ARTHREX SUTURE (UHMWPE)GAT2012-09-25
1388121532025402K121124ARTHREX MIXING AND DELIVERY SYSTEMFMF2012-05-16
1388121614707002K120044ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELEDKWS2012-03-08
1388121322981987K112990ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLEHTY2011-12-19
1388121245165659K111253ARTHREX DISTAL EXTREMITY PLATE SYSTEMHRS2011-08-02
1388121198919747K110123PCL TIGHTROPEHTY2011-04-28
1388121234502965K103705LOW PROFILE SCREWSHWC2011-03-18
1388121296138155K103466ARTHREX UNIVERS II SHOULDER PROSTHESISKWS2010-12-22
1388121641939908K100652ACL TIGHTROPEHTY2010-06-23
1388121053522637K090107MINI TIGHTROPEHTN2009-08-06
1388121887136300K073149MENISCAL CINCHGAT2008-02-11
1388121103054165K071032ARTHREX UNIVERS II SHOULDER PROSTHESISKWS2007-08-20
1388121478156746K063058ARTHREX ANATOEMIC PHALANGEAL PROSTHESISKWD2007-01-03
1388121089927657K062747ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MMHRS2006-09-29
1388121802524207K062365ARTHREX ASPIRATE KITFMF2006-09-29
1388122018495756K052614LOW PROFILE PLATE AND SCREW SYSTEMHRS2005-09-28
1388121828708923K043248TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DSHTN2005-02-16
1388121633499286K041965ARTHREX HUMERAL FRACTURE PLATES AND SCREWSHRS2004-09-08
1388122036876328K041553ARTHREX SUTURE GRAFTING KITGAT2004-12-10
1388121767566092K023986ARTHREX OPES ELECTRODES AND ACCESSORIESGEI2002-12-17
1388121853111819K020345ARTHREX UNIVERS FRACTURE PROSTHESISKWS2002-09-06
1388121484714322K014158ENDOSCOPIC CAMERA TC804/C4GCJ2002-03-14
1388121944570179K010124ARTHREX UNIVERS 30 SHOULDER PROSTHESISKWS2001-04-06
1388122008493535BK110046
1388121607743040
1388121715601290
1388121161084072
1388121267391307
1388121271608110
1388121329899805
1388121353211118
1388121369543475
1388121478235089
1388121480176254
1388121562318437
1388121916205510
1388121984404142
1388122006747056
1388122027038358
1388122030039678

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS52013-07-03
KWS52012-03-08
HWC32017-05-11
GAT32012-09-25
HTY32011-12-19
FMF22012-05-16
HTN22009-08-06
HRX21996-10-10
HSD12016-04-19
PHX12014-11-25
MBI12012-12-21
KWD12007-01-03
GEI12002-12-17
GCJ12002-03-14
JDR11995-02-01