FDA.reportPublic FDA data

Arthrex Distribution Hub EMEA B.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30168513793016851379Arthrex Distribution Hub EMEA B.V.1N2026-01-01Amperestraat 9 Venlo Limburg NL 5928 PE

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2913621496666919K983843BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238BMAI1999-03-12
2913621415905884K982743DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBHGEI1998-09-14
2913621312915195K973812ARTHREX PUDDU OSTEOTOMY SYSTEMHRS1998-06-10
2913621196806715K971723FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)MBI1997-07-30
2913621201265194K961228KARL STORZ MAGNIFYING ARTHROSOCPESHRX1996-10-10
2913621370672514K943492ARTHREX STAPLESJDR1995-02-01
2913621508377083K943154KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHSHRX1994-12-06
2913621943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
2913621635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
2913621512532981K915721MODEL AR-6300 INFUSION PUMPHRX1992-03-19
2913621666311898K915424ARTHREX CANNULATED INTERFERENCE SCREWHWC1993-02-09
2913621686459874K792558CONTAINER SYSTEMFLE1979-12-27
2913621534704471K241361Arthrex Synergy Vision Endoscopic Imaging SystemGCJ2024-07-25
2913621673854296K241235Arthrex TightRope IIMBI2024-05-29
2913621121776559K232973Arthrex Knee FiberTak® Button Suture AnchorMBI2023-11-15
2913621477854555K232755Arthrex FiberTape and TigerTape Cerclage SuturesHTN2023-10-06
2913621778673636K232340Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorMBI2023-09-01
2913621997653298K231857Arthrex TightRope IIMBI2023-08-08
2913621570822525K231113Arthrex FiberTak Suture AnchorMBI2023-05-18
2913621790700568K230904Arthrex Virtual Implant Positioning (VIP) SystemQHE2023-06-22
2913621443177867K223759Arthrex SynergyID Endoscopic Imaging SystemGCJ2023-02-24
2913621573876330K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemHRS2022-10-03
2913621650670333K222263Arthrex Self Punching SwiveLock Suture AnchorsMAI2022-08-26
2913621847479353K222244Arthrex 3.5 mm Locking Compression PlatesHRS2022-09-30
2913621765245744K222161Arthrex Knotless FiberTak Biceps Suture AnchorMBI2022-08-11
2913621700524171K222078Arthrex SoftStitchGAT2022-09-14
2913621708862739K221485Arthrex FiberTape and TigerTape Cerclage SuturesHTN2022-08-22
2913621356488615K221396Arthrex FiberTak Suture AnchorMBI2022-12-22
2913621924876573K221354Arthrex SutureTapeGAT2022-09-09
2913621684588912K221099Arthrex Self-Punching PushLock Suture AnchorMAI2022-05-13
2913621719519637K220947Arthrex Knotless AC Repair DevicesHTN2022-06-06
2913621637842578K220937Arthrex Mini Fragment SystemHRS2022-06-29
2913621677258678K220839Arthrex Compression FT PinsHWC2022-09-19
2913622030593424K213837Arthrx Fracture PlatesHRS2022-05-02
2913621586216255K213644Arthrex Knotless Mini TightRopesHTN2021-12-17
2913622052033385K210994Arthrex Beveled FT ScrewsHWC2021-06-01
2913621110199596K203834Arthrex Patella SuturePlatesHRS2021-03-25
2913621729344289K203495Arthrex SwiveLock AnchorMAI2021-04-19
2913622059887981K203294Arthrex Pilon Fusion SystemHRS2021-02-03
2913621641866470K203268Arthrex FiberTak Suture AnchorMBI2020-11-27
2913621012772476K203239Arthrex Low Profile ScrewsHWC2020-12-30
2913621737370116K203180Arthrex DynaNite Nitinol StaplesJDR2020-12-16
2913621150863470K203100Arthrex Eclipse Titanium Humeral HeadPKC2020-11-20
2913621800369969K202581Arthrex TightRope IIMBI2020-11-04
2913622048636012K202535Arthrex FastThread Interference ScrewMAI2020-11-18
2913621567733028K202444Knotless TensionTight Button Implant SystemMBI2020-11-17
2913621451325155K201786Arthrex Mini Hip PushLockMAI2020-07-30
2913621415780078K201749Arthrex SwiveLock AnchorMAI2020-08-21
2913621233418372K201677Arthrex Mesh PlatesHRS2020-09-02
2913621112476228K201542Arthrex Eclipse Shoulder Prosthesis SystemPKC2020-07-08
2913622002253262K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemHTN2020-09-03
2913621327473572K201235Arthrex MaxForce MTP Compression Plates and ScrewsHRS2020-07-06
2913621064571647K201134Arthrex NanoScope SystemGCJ2020-09-04
2913621127854339K201132Arthrex Compression ScrewsHRS2020-07-27
2913621590923911K200895Univers Revers Modular Glenoid System, Half Augment BaseplatePHX2020-08-13
2913621125092504K200433iBalance UKA Tibial Tray ImplantHSX2020-03-17
2913621677870257K200341Arthrex FiberTak Suture AnchorMBI2020-03-12
2913621264856128K200068Arthrex DynaNite K-WireHTY2020-06-29
2913621895565053K193575Arthrex SutureTapeGAT2020-07-24
2913621560992220K193523ArthrexVIP Web PortalLLZ2020-04-30
2913621760716052K193503Arthrex SwiveLock Suture AnchorMAI2020-01-15
2913621617796149K193372Univers Revers Modular Glenoid System (Augemented baseplates)PHX2020-01-10
2913621663630021K193345Arthrex DynaNite Compression PlateHRS2020-07-08
2913621658902892K193157Arthrex 3.9mm Corkscrew Suture AnchorMAI2019-12-12
2913621087212927K193156Arthrex Mini Comprehensive Fixation System - 1.0mm ScrewsHWC2020-02-10
2913621963871070K192532Arthrex SwiveLock AnchorMAI2019-10-19
2913621865089875K192441Arthrex SwiveLock AnchorsMAI2019-10-17
2913621134440478K191960Arthrex Univers Revers Modular Glenoid SystemPHX2019-12-23
2913621747445400K191651Arthrex Nano SwiveLock Suture AnchorHWC2019-11-06
2913621624813494K191426FiberTak ButtonMBI2019-11-26
2913621556267380K191344Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm ModuleHRS2019-10-03
2913622029854750K191326Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm ModuleHRS2019-10-15
2913621220515949K191226Arthrex SwiveLock Suture AnchorMAI2019-06-11
2913621953033797K190953Arthrex Minimally Invasive Ankle Fusion PlateHRS2019-10-16
2913621442596231K190921Arthrex Low Profile ScrewsHWC2019-10-30
2913621956871339K190707Arthrex SoftStitchGAT2020-10-02
2913621581053510K190645Arthrex NanoScope SystemGCJ2019-07-05
2913621769732362K190288Arthrex Tenodesis ButtonMBI2019-09-13
2913621716679293K190287Arthrex DynaNite® PIP (Hammertoe) ImplantHTY2019-05-03
2913621527032736K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWireMBI2019-05-19
2913621784543545K183628Arthrex TensionLoc SystemHWC2019-03-26
2913621176519828K183395Arthrex 2.5 mm Tenodesis ScrewHWC2019-04-17
2913621416729640K183194Arthrex Eclipse Shoulder Prosthesis SystemQHQ2019-07-26
2913621975010618K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsKWS2019-03-08
2913621234466108K182361Arthrex Compression FT ScrewsHWC2018-12-18
2913621378152771K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayPHX2018-09-28
2913621202533516K181769Arthrex FiberTak Suture AnchorMBI2018-09-21
2913621493062547K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisKWS2018-12-21
2913621777769153K181513Arthrex PushLock Tenodesis AnchorMBI2018-08-30
2913621769392760K180768Arthrex SwiveLock AnchorsMAI2018-12-14
2913622056430873K180662Arthrex FastThread Interference ScrewMAI2018-05-22
2913621329878334K180594Knotless SutureTak AnchorsMAI2018-06-22
2913622044871540K180118Arthrex NanoSuture AnchorMBI2018-02-12
2913621335834251K173900Arthrex Univers Revers Modular Glenoid SystemPHX2018-04-20
2913621005367378K173845Arthrex SwiveLockMBI2018-08-06
2913621678633281K173788Arthrex Corkscrew FTMAI2018-03-01
2913621536282979K173656Arthrex FibuLock NailHSB2018-07-26
2913621551400221K173381Nexxis ORDXJ2018-02-22
2913621316114438K173240Arthrex PushLockMAI2018-01-16
2913621488723877K172612FiberTak DXMBI2017-09-28
2913621043499957K172371Arthrex UNIVERS REVERS COATED BASEPLATEPHX2018-03-22
2913621025499269K172052Arthrex DynaNite Nitinol StapleJDR2017-12-13
2913622018011279K171869Sutter CURIS RF GeneratorGEI2018-02-23
2913621310879820K171841Arthrex Shoulder SystemKWS2018-03-29
2913621722767889K171365Arthrex Knee SystemsMBH2017-11-07
2913621224093471K171296SutureTapeGAT2017-05-26
2913621865469897K171020Arthrex Knotless SutureTak AnchorMBI2017-05-16
2913621899130158K170547Arthrex Mesh Plate SystemHRS2017-09-01
2913622039112265K170414Arthrex Univers Revers Apex Humeral StemsPHX2017-12-14
2913622059197007K170382Arthrex Compression ScrewsHWC2017-05-11
2913621035030731K170206Arthrex FiberTape CerclageJDQ2017-11-15
2913621607839547K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web PortalKWS2017-02-10
2913621335387532K161782Arthrex Univers Revers Shoulder Prosthesis SystemHSD2016-11-21
2913621664019313K161581Arthrex Synergy RF SystemGEI2016-09-09
2913621039636825K161371Sonoma Fifth Metatarsal Repair SystemHSB2017-02-24
2913621342083027K161108Arthrex VaultLock GlenoidKWS2016-08-29
2913621166566984K161060Arthrex iBalance UKA System Vitamin E Tibial BearingHSX2016-12-15
2913621820351979K160461Arthrex iBalance BiCompartmental Arthroplasty SystemKRR2016-04-12
2913621113239248K160319FiberTak DRMBI2016-05-10
2913621919499415K160069Sonoma Fibula Repair SystemHSB2016-03-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS342022-10-03
MBI332024-05-29
MAI322022-08-26
HWC282022-09-19
KWS152019-03-08
HTN122023-10-06
GAT122022-09-14
HTY102020-06-29
PHX82020-08-13
GCJ72024-07-25
HRX72009-08-03
GEI62018-02-23
HSB52018-07-26
JDR42020-12-16
HSX42020-03-17
JWH42014-11-19
MQV42011-01-10
LLZ32020-04-30
MBH32017-11-07
HSD32016-11-21
FMF32012-05-16
PKC22020-11-20
KRR22016-04-12
FRO22009-04-08
QHE12023-06-22
QHQ12019-07-26
DXJ12018-02-22
JDQ12017-11-15
PLF12015-08-12
KWY12008-07-08
JDI12008-06-02
KWD12007-01-03
FRG12006-02-15
LZB12005-11-29
HWE11994-01-25
FLE11979-12-27