FDA.reportPublic FDA data

Arthrex Colombia SAS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30212264193021226419Arthrex Colombia SAS1N2027-01-01Carrera 11 No. 79-35 Piso 9 Bogota Cundinamarca CO 110221

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3005551341652135K953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIESHRX1996-01-22
3005551943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
3005551512532981K915721MODEL AR-6300 INFUSION PUMPHRX1992-03-19
3005551235537325K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
3005551534704471K241361Arthrex Synergy Vision Endoscopic Imaging SystemGCJ2024-07-25
3005551121776559K232973Arthrex Knee FiberTak® Button Suture AnchorMBI2023-11-15
3005551477854555K232755Arthrex FiberTape and TigerTape Cerclage SuturesHTN2023-10-06
3005551997653298K231857Arthrex TightRope IIMBI2023-08-08
3005551570822525K231113Arthrex FiberTak Suture AnchorMBI2023-05-18
3005551443177867K223759Arthrex SynergyID Endoscopic Imaging SystemGCJ2023-02-24
3005551356488615K221396Arthrex FiberTak Suture AnchorMBI2022-12-22
3005551762055344K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIMAI2022-10-05
3005551641866470K203268Arthrex FiberTak Suture AnchorMBI2020-11-27
3005551012772476K203239Arthrex Low Profile ScrewsHWC2020-12-30
3005551800369969K202581Arthrex TightRope IIMBI2020-11-04
3005552048636012K202535Arthrex FastThread Interference ScrewMAI2020-11-18
3005551064571647K201134Arthrex NanoScope SystemGCJ2020-09-04
3005551677870257K200341Arthrex FiberTak Suture AnchorMBI2020-03-12
3005551747445400K191651Arthrex Nano SwiveLock Suture AnchorHWC2019-11-06
3005551176519828K183395Arthrex 2.5 mm Tenodesis ScrewHWC2019-04-17
3005551202533516K181769Arthrex FiberTak Suture AnchorMBI2018-09-21
3005551316114438K173240Arthrex PushLockMAI2018-01-16
3005551488723877K172612FiberTak DXMBI2017-09-28
3005551029999017K172385Clarius Ultrasound SystemIYN2017-09-14
3005551039214845K163138Clarius Ultrasound SystemIYN2016-11-30
3005551664019313K161581Arthrex Synergy RF SystemGEI2016-09-09
3005551977969827K153513Insufflator 50L FM134HIF2016-03-04
3005551502380968K153218Arthrex Synergy UHD4 SystemGCJ2016-02-12
3005551527350284K151732Arthrex Fracture PlatesHRS2015-08-28
3005551929763876K151543Graft Delivery Device with Integrated StyletFMF2015-07-07
3005551089423870K151230Arthrex FiberTak AnchorsMBI2015-06-19
3005551058487816K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mmMBI2015-08-20
3005551193547645K143614Arthrex Low Profile ScrewsHWC2015-01-16
3005551628979145K143139Arthrex Fracture SystemHRS2015-01-16
3005551355680668K141577ARTHREX PIP DARTHTY2014-07-18
3005551174836862K141478ARTHREX FRACTURE PLATES AND SCREWSHRS2014-07-08
3005552046443797K133275MINI TIGHTROPEHTN2014-01-30
3005551344277907K132043ARTHREX SPEEDCINCHGAT2013-07-31
3005551505762157K130458KNOTLESS FIBERTAK SUTURE ANCHORMBI2013-05-03
3005551940918789K123341ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTONMBI2012-12-21
3005551786890192K122208EXTERNAL FIXATOR SYSTEMNDK2012-12-20
3005551532025402K121124ARTHREX MIXING AND DELIVERY SYSTEMFMF2012-05-16
3005551322981987K112990ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLEHTY2011-12-19
3005551234502965K103705LOW PROFILE SCREWSHWC2011-03-18
3005551991797874K103060ARTHREX TIBIAL GRAFTBOLTMBI2011-01-05
3005551056593767K101679ARTHREX PUSHLOCK ANCHORSMAI2010-10-22
3005551641939908K100652ACL TIGHTROPEHTY2010-06-23
3005551794093700K093912ARTHREX TIBIAL GRAFTBOLTMBI2010-03-18
3005551213698332K093343GRAFTY QUICKSETMQV2010-04-22
3005551053522637K090107MINI TIGHTROPEHTN2009-08-06
3005551694342628K083707ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICEHRX2009-08-03
3005551015150221K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEHRX2008-03-18
3005551887136300K073149MENISCAL CINCHGAT2008-02-11
3005551118173825K071756ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTUREGCJ2007-08-15
3005551312995926K071456ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANTMAI2008-01-17
3005551089927657K062747ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MMHRS2006-09-29
3005551978667268K062466ARTHREX INTERFERENCE SCREWMAI2006-11-29
3005551802524207K062365ARTHREX ASPIRATE KITFMF2006-09-29
3005551776737743K053543ARTHREX ARTHOERESIS IMPLANTHWC2006-04-03
3005552019525600K052776TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBDHTN2005-12-13
3005551063008414K051726ARTHREX TENODESIS FAMILYHWC2005-09-27
3005551828708923K043248TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DSHTN2005-02-16
3005551870300229K031666ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DSHRS2003-11-18
3005551821770513K03083740 L HIGH FLOW INSUFFLATOR F108HIF2004-02-05
3005551809540857K024291ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475HRX2003-03-20
3005551767566092K023986ARTHREX OPES ELECTRODES AND ACCESSORIESGEI2002-12-17
3005551723796612K022234ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322BHWC2002-10-03
3005551767426967K021434ARTHREX FIBERWIRE IN USP SIZESGAT2002-11-07
3005551195528418K002469IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)EBW2001-02-07
3005551823320126BK241060
3005551257612176BK210655
3005551931821505BK200442
3005551034045755
3005551161084072
3005551192375044
3005551267391307
3005551271608110
3005551304734689
3005551310387745
3005551353211118
3005551369543475
3005551401594004
3005551409456947
3005551441412956
3005551478235089
3005551480176254
3005551562318437
3005551704576765
3005551715601290
3005551732451202
3005551751876675
3005551821510143
3005551877263918
3005551916205510
3005551935228528
3005552006747056

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI152023-11-15
HWC82020-12-30
GCJ62024-07-25
MAI62022-10-05
HTN52023-10-06
HRS52015-08-28
HRX52009-08-03
FMF32015-07-07
HTY32014-07-18
GAT32013-07-31
IYN22017-09-14
GEI22016-09-09
HIF22016-03-04
NDK12012-12-20
MQV12010-04-22
EBW12001-02-07
FST11990-04-23