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
30309269593030926959Arthrex Logistic Center Canada1N2026-01-01580 Sovereign Road London Ontario CA N5V 4K7

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
3275371943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
3275371635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
3275371235537325K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
3275371625322811K882958SONY VIDEO PRINTERS, UP SERIESKQM1988-08-04
3275371673854296K241235Arthrex TightRope IIMBI2024-05-29
3275371121776559K232973Arthrex Knee FiberTak® Button Suture AnchorMBI2023-11-15
3275371443177867K223759Arthrex SynergyID Endoscopic Imaging SystemGCJ2023-02-24
3275371768161671K223284SutureLoc™ ImplantMBI2023-02-02
3275371224681026K221031Arthrex DualCompression Hindfoot Fusion Nail Implant SystemHSB2022-12-20
3275371327473572K201235Arthrex MaxForce MTP Compression Plates and ScrewsHRS2020-07-06
3275371064571647K201134Arthrex NanoScope SystemGCJ2020-09-04
3275371442596231K190921Arthrex Low Profile ScrewsHWC2019-10-30
3275371874538785K180533Procellera Composite Antibacterial Wound DressingFRO2018-12-10
1388122059197007K170382Arthrex Compression ScrewsHWC2017-05-11
3275371664019313K161581Arthrex Synergy RF SystemGEI2016-09-09
3275371502380968K153218Arthrex Synergy UHD4 SystemGCJ2016-02-12
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
3275371015150221K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEHRX2008-03-18
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
3275371821770513K03083740 L HIGH FLOW INSUFFLATOR F108HIF2004-02-05
3275371809540857K024291ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475HRX2003-03-20
1388121767566092K023986ARTHREX OPES ELECTRODES AND ACCESSORIESGEI2002-12-17
1388121853111819K020345ARTHREX UNIVERS FRACTURE PROSTHESISKWS2002-09-06
1388121484714322K014158ENDOSCOPIC CAMERA TC804/C4GCJ2002-03-14
3275371572638328K014068ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115EBW2002-05-03
1388121944570179K010124ARTHREX UNIVERS 30 SHOULDER PROSTHESISKWS2001-04-06
1388122008493535BK110046
3275372008493535BK110046
1388121607743040
1388121715601290
3275371161084072
1388121161084072
3275371192375044
3275371237667726
3275371267391307
1388121267391307
1388121271608110
3275371271608110
3275371304734689
3275371310387745
1388121329899805
1388121353211118
3275371353211118
1388121369543475
3275371369543475
3275371401594004
3275371441412956
1388121478235089
1388121480176254
1388121562318437
3275371647902187
3275371732451202
3275371751876675
3275371821510143
1388121916205510
3275371935228528
1388121984404142
1388122006747056
1388122027038358
1388122030039678

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS62020-07-06
GCJ52023-02-24
KWS52012-03-08
MBI42024-05-29
HWC42019-10-30
HRX42008-03-18
GAT32012-09-25
HTY32011-12-19
GEI22016-09-09
FMF22012-05-16
HTN22009-08-06
HSB12022-12-20
FRO12018-12-10
HSD12016-04-19
PHX12014-11-25
KWD12007-01-03
HIF12004-02-05
EBW12002-05-03
JDR11995-02-01
HWE11994-01-25
FST11990-04-23
KQM11988-08-04