FDA.report

Arthrex GmbH

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30025791363002579136Arthrex GmbH1N2026-01-01Erwin-Hielscher-Strasse 9 Munich Bavaria DE 81249
30071935053007193505ARTHREX GMBH1N2026-01-01Oskar-von-Miller Strasse 6 Odelzhausen Bavaria DE 85235

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1772941201265194K961228KARL STORZ MAGNIFYING ARTHROSOCPESHRX1996-10-10
1771801370672514K943492ARTHREX STAPLESJDR1995-02-01
1772941370672514K943492ARTHREX STAPLESJDR1995-02-01
1772941508377083K943154KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHSHRX1994-12-06
1772941943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
1772941635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
1772941173826867K921119ARTHREX ARTHROSCOPEHRX1994-04-15
1772941512532981K915721MODEL AR-6300 INFUSION PUMPHRX1992-03-19
1772941686459874K792558CONTAINER SYSTEMFLE1979-12-27
1772941534704471K241361Arthrex Synergy Vision Endoscopic Imaging SystemGCJ2024-07-25
1772941673854296K241235Arthrex TightRope IIMBI2024-05-29
1772941121776559K232973Arthrex Knee FiberTak® Button Suture AnchorMBI2023-11-15
1772941477854555K232755Arthrex FiberTape and TigerTape Cerclage SuturesHTN2023-10-06
1772941778673636K232340Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorMBI2023-09-01
1772941997653298K231857Arthrex TightRope IIMBI2023-08-08
1772941570822525K231113Arthrex FiberTak Suture AnchorMBI2023-05-18
1772941790700568K230904Arthrex Virtual Implant Positioning (VIP) SystemQHE2023-06-22
1772941443177867K223759Arthrex SynergyID Endoscopic Imaging SystemGCJ2023-02-24
1772941573876330K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemHRS2022-10-03
1772941650670333K222263Arthrex Self Punching SwiveLock Suture AnchorsMAI2022-08-26
1772941847479353K222244Arthrex 3.5 mm Locking Compression PlatesHRS2022-09-30
1772941765245744K222161Arthrex Knotless FiberTak Biceps Suture AnchorMBI2022-08-11
1772941700524171K222078Arthrex SoftStitchGAT2022-09-14
1772941120566425K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWireMBI2022-09-07
1772941708862739K221485Arthrex FiberTape and TigerTape Cerclage SuturesHTN2022-08-22
1772941356488615K221396Arthrex FiberTak Suture AnchorMBI2022-12-22
1772941924876573K221354Arthrex SutureTapeGAT2022-09-09
1772941684588912K221099Arthrex Self-Punching PushLock Suture AnchorMAI2022-05-13
1772941719519637K220947Arthrex Knotless AC Repair DevicesHTN2022-06-06
1772941637842578K220937Arthrex Mini Fragment SystemHRS2022-06-29
1772941677258678K220839Arthrex Compression FT PinsHWC2022-09-19
1772942030593424K213837Arthrx Fracture PlatesHRS2022-05-02
1772941586216255K213644Arthrex Knotless Mini TightRopesHTN2021-12-17
1772942052033385K210994Arthrex Beveled FT ScrewsHWC2021-06-01
1772941264043169K210050Augmented VaultLock GlenoidKWS2021-06-07
1772941729344289K203495Arthrex SwiveLock AnchorMAI2021-04-19
1772942059887981K203294Arthrex Pilon Fusion SystemHRS2021-02-03
1772941641866470K203268Arthrex FiberTak Suture AnchorMBI2020-11-27
1772941800369969K202581Arthrex TightRope IIMBI2020-11-04
1772942048636012K202535Arthrex FastThread Interference ScrewMAI2020-11-18
1772941567733028K202444Knotless TensionTight Button Implant SystemMBI2020-11-17
1772941112476228K201542Arthrex Eclipse Shoulder Prosthesis SystemPKC2020-07-08
1772942002253262K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemHTN2020-09-03
1772941327473572K201235Arthrex MaxForce MTP Compression Plates and ScrewsHRS2020-07-06
1772941064571647K201134Arthrex NanoScope SystemGCJ2020-09-04
1772941127854339K201132Arthrex Compression ScrewsHRS2020-07-27
1772941677870257K200341Arthrex FiberTak Suture AnchorMBI2020-03-12
1772941895565053K193575Arthrex SutureTapeGAT2020-07-24
1772941760716052K193503Arthrex SwiveLock Suture AnchorMAI2020-01-15
1772941617796149K193372Univers Revers Modular Glenoid System (Augemented baseplates)PHX2020-01-10
1772941658902892K193157Arthrex 3.9mm Corkscrew Suture AnchorMAI2019-12-12
1772941624813494K191426FiberTak ButtonMBI2019-11-26
1772941556267380K191344Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm ModuleHRS2019-10-03
1772942029854750K191326Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm ModuleHRS2019-10-15
1772941220515949K191226Arthrex SwiveLock Suture AnchorMAI2019-06-11
1772941527032736K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWireMBI2019-05-19
1772941176519828K183395Arthrex 2.5 mm Tenodesis ScrewHWC2019-04-17
1772941416729640K183194Arthrex Eclipse Shoulder Prosthesis SystemQHQ2019-07-26
1772941378152771K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayPHX2018-09-28
1772941202533516K181769Arthrex FiberTak Suture AnchorMBI2018-09-21
1772941493062547K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisKWS2018-12-21
1771801329878334K180594Knotless SutureTak AnchorsMAI2018-06-22
1772941329878334K180594Knotless SutureTak AnchorsMAI2018-06-22
1772941335834251K173900Arthrex Univers Revers Modular Glenoid SystemPHX2018-04-20
1772941005367378K173845Arthrex SwiveLockMBI2018-08-06
1772941678633281K173788Arthrex Corkscrew FTMAI2018-03-01
1772941551400221K173381Nexxis ORDXJ2018-02-22
1772941316114438K173240Arthrex PushLockMAI2018-01-16
1772941488723877K172612FiberTak DXMBI2017-09-28
1772942018011279K171869Sutter CURIS RF GeneratorGEI2018-02-23
1772941722767889K171365Arthrex Knee SystemsMBH2017-11-07
1772941224093471K171296SutureTapeGAT2017-05-26
1772941899130158K170547Arthrex Mesh Plate SystemHRS2017-09-01
1772941607839547K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web PortalKWS2017-02-10
1772941335387532K161782Arthrex Univers Revers Shoulder Prosthesis SystemHSD2016-11-21
1772941664019313K161581Arthrex Synergy RF SystemGEI2016-09-09
1772941342083027K161108Arthrex VaultLock GlenoidKWS2016-08-29
1772941820351979K160461Arthrex iBalance BiCompartmental Arthroplasty SystemKRR2016-04-12
1772941527350284K151732Arthrex Fracture PlatesHRS2015-08-28
1772941266212086K151342Arthrex SwiveLock AnchorsMAI2016-03-24
1772941058487816K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mmMBI2015-08-20
1772941860300877K150456Arthrex Plates, Screws, and StaplesHRS2015-04-29
1772941719236720K143702Arthrex Blunt Tip Screws with Fiber TapeHTY2015-04-09
1772941193547645K143614Arthrex Low Profile ScrewsHWC2015-01-16
1772941772694788K142863Univers Rivers Shoulder Prosthesis SystemPHX2014-11-25
1772941057869136K141735ARTHREX ANKLE FUSION PLATING SYSTEMHRS2014-08-15
1772941174836862K141478ARTHREX FRACTURE PLATES AND SCREWSHRS2014-07-08
1772941918508286K140855ARTHREX SUTURETAK SUTURE ANCHORSMAI2014-12-18
1772942046443797K133275MINI TIGHTROPEHTN2014-01-30
1772941799940458K131633ARTHREX UNIVERS APEXKWS2013-09-27
1772941505762157K130458KNOTLESS FIBERTAK SUTURE ANCHORMBI2013-05-03
1772941137450500K130129UNIVERS REVERS SHOULDER PROSTHESIS SYSTEMKWS2013-05-31
1772941701196858K123241ARTHREX FRACTURE PLATESHRS2013-04-05
1772941547827721K122374ARTHREX SUTURE (UHMWPE)GAT2012-09-25
1772941532025402K121124ARTHREX MIXING AND DELIVERY SYSTEMFMF2012-05-16
1772941614707002K120044ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELEDKWS2012-03-08
1772941322981987K112990ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLEHTY2011-12-19
1772941379357695K112237MICROSUTURE ANCHORSHWC2011-09-02
1772941953352889K112040ARTHREX BIOCOMPOSITE TRANSFIXMAI2011-12-15
1771801245165659K111253ARTHREX DISTAL EXTREMITY PLATE SYSTEMHRS2011-08-02
1772941381765463K110660ARTHREX BIOCOMPOSITE SUTURETAKMAI2011-03-31
1772941404419440K101823ARTHREX SWIVELOCK ANCHORSMAI2011-01-07
1772941056593767K101679ARTHREX PUSHLOCK ANCHORSMAI2010-10-22
1772941635503371K091844ARTHREX BIO-COMPOSITE SUTURETAK ANCHORSMAI2009-08-28
1772941053522637K090107MINI TIGHTROPEHTN2009-08-06
1771801694342628K083707ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICEHRX2009-08-03
1772941694342628K083707ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICEHRX2009-08-03
1772941065815982K083435ARTHREX UNIVERS II SHOULDER PEGGED GLENOIDKWS2009-06-26
1772941854431757K082999ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DARTMAI2008-12-30
1772941558252275K082810ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREWMAI2009-01-23
1772941015150221K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEHRX2008-03-18
1772942023594562K080111ARTHREX COMPRESSION STAPLEJDR2008-02-13

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MAI232022-08-26
HRS202022-10-03
MBI192024-05-29
KWS152021-06-07
HWC122022-09-19
HRX122009-08-03
HTN92023-10-06
GCJ82024-07-25
GAT82022-09-14
GEI52018-02-23
FMF52012-05-16
PHX42020-01-10
HTY42015-04-09
KWD42007-01-03
JDR32008-02-13
MQV22004-05-12
HWE21994-01-25
QHE12023-06-22
PKC12020-07-08
QHQ12019-07-26
DXJ12018-02-22
MBH12017-11-07
HSD12016-11-21
KRR12016-04-12
KTT12007-08-29
FRG12006-02-15
MNU12001-06-19
FLE11979-12-27