FDA.reportPublic FDA data

Arthrex Australia Pty Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30192692983019269298Arthrex Australia Pty Ltd.1N2027-01-01Suite 501, 20 Rodborough Road Frenchs Forest New South Wales AU 2086

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2962021415905884K982743DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBHGEI1998-09-14
2962021196806715K971723FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)MBI1997-07-30
2962021201265194K961228KARL STORZ MAGNIFYING ARTHROSOCPESHRX1996-10-10
2962021370672514K943492ARTHREX STAPLESJDR1995-02-01
2962021943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
2962021635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
2962021173826867K921119ARTHREX ARTHROSCOPEHRX1994-04-15
2962021625322811K882958SONY VIDEO PRINTERS, UP SERIESKQM1988-08-04
2962021534704471K241361Arthrex Synergy Vision Endoscopic Imaging SystemGCJ2024-07-25
2962021121776559K232973Arthrex Knee FiberTak® Button Suture AnchorMBI2023-11-15
2962021778673636K232340Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorMBI2023-09-01
2962021997653298K231857Arthrex TightRope IIMBI2023-08-08
2962021546046700K231330FiberTak® Suture AnchorMBI2023-06-01
2962021570822525K231113Arthrex FiberTak Suture AnchorMBI2023-05-18
2962021242851426K230976Arthrex Radiopaque FiberTape Cerclage suturesJDQ2023-08-24
2962021695834345K230568FiberTak Suture AnchorMBI2023-04-01
2962021440889354K230433Arthrex Knotless FiberTak Suture AnchorMBI2023-03-10
2962021768161671K223284SutureLoc™ ImplantMBI2023-02-02
2962021573876330K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemHRS2022-10-03
2962021650670333K222263Arthrex Self Punching SwiveLock Suture AnchorsMAI2022-08-26
2962021847479353K222244Arthrex 3.5 mm Locking Compression PlatesHRS2022-09-30
2962021765245744K222161Arthrex Knotless FiberTak Biceps Suture AnchorMBI2022-08-11
2962021120566425K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWireMBI2022-09-07
2962021708862739K221485Arthrex FiberTape and TigerTape Cerclage SuturesHTN2022-08-22
2962021224681026K221031Arthrex DualCompression Hindfoot Fusion Nail Implant SystemHSB2022-12-20
2962021719519637K220947Arthrex Knotless AC Repair DevicesHTN2022-06-06
2962021637842578K220937Arthrex Mini Fragment SystemHRS2022-06-29
2962021677258678K220839Arthrex Compression FT PinsHWC2022-09-19
2962022030593424K213837Arthrx Fracture PlatesHRS2022-05-02
2962021586216255K213644Arthrex Knotless Mini TightRopesHTN2021-12-17
2962021710908924K212146Arthrex LoopLoc Knotless SutureGAT2021-10-25
2962021110199596K203834Arthrex Patella SuturePlatesHRS2021-03-25
2962021729344289K203495Arthrex SwiveLock AnchorMAI2021-04-19
2962022059887981K203294Arthrex Pilon Fusion SystemHRS2021-02-03
2962021641866470K203268Arthrex FiberTak Suture AnchorMBI2020-11-27
2962021012772476K203239Arthrex Low Profile ScrewsHWC2020-12-30
2962021737370116K203180Arthrex DynaNite Nitinol StaplesJDR2020-12-16
2962021816684943K202582Arthrex SynergyID Endoscopic Imaging SystemGCJ2021-07-22
2962021800369969K202581Arthrex TightRope IIMBI2020-11-04
2962021567733028K202444Knotless TensionTight Button Implant SystemMBI2020-11-17
2962021233418372K201677Arthrex Mesh PlatesHRS2020-09-02
2962021112476228K201542Arthrex Eclipse Shoulder Prosthesis SystemPKC2020-07-08
2962022002253262K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemHTN2020-09-03
2962021327473572K201235Arthrex MaxForce MTP Compression Plates and ScrewsHRS2020-07-06
2962021064571647K201134Arthrex NanoScope SystemGCJ2020-09-04
2962021127854339K201132Arthrex Compression ScrewsHRS2020-07-27
2962021677870257K200341Arthrex FiberTak Suture AnchorMBI2020-03-12
2962021264856128K200068Arthrex DynaNite K-WireHTY2020-06-29
2962021895565053K193575Arthrex SutureTapeGAT2020-07-24
2962021760716052K193503Arthrex SwiveLock Suture AnchorMAI2020-01-15
2962021617796149K193372Univers Revers Modular Glenoid System (Augemented baseplates)PHX2020-01-10
2962021663630021K193345Arthrex DynaNite Compression PlateHRS2020-07-08
2962021658902892K193157Arthrex 3.9mm Corkscrew Suture AnchorMAI2019-12-12
2962021747445400K191651Arthrex Nano SwiveLock Suture AnchorHWC2019-11-06
2962021556267380K191344Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm ModuleHRS2019-10-03
2962022029854750K191326Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm ModuleHRS2019-10-15
2962021220515949K191226Arthrex SwiveLock Suture AnchorMAI2019-06-11
2962021953033797K190953Arthrex Minimally Invasive Ankle Fusion PlateHRS2019-10-16
2962021442596231K190921Arthrex Low Profile ScrewsHWC2019-10-30
2962021769732362K190288Arthrex Tenodesis ButtonMBI2019-09-13
2962021716679293K190287Arthrex DynaNite® PIP (Hammertoe) ImplantHTY2019-05-03
2962021176519828K183395Arthrex 2.5 mm Tenodesis ScrewHWC2019-04-17
2962021416729640K183194Arthrex Eclipse Shoulder Prosthesis SystemQHQ2019-07-26
2962021202533516K181769Arthrex FiberTak Suture AnchorMBI2018-09-21
2962021777769153K181513Arthrex PushLock Tenodesis AnchorMBI2018-08-30
2962022056430873K180662Arthrex FastThread Interference ScrewMAI2018-05-22
2962021329878334K180594Knotless SutureTak AnchorsMAI2018-06-22
2962022044871540K180118Arthrex NanoSuture AnchorMBI2018-02-12
2962021335834251K173900Arthrex Univers Revers Modular Glenoid SystemPHX2018-04-20
2962021005367378K173845Arthrex SwiveLockMBI2018-08-06
2962021678633281K173788Arthrex Corkscrew FTMAI2018-03-01
2962021536282979K173656Arthrex FibuLock NailHSB2018-07-26
2962021551400221K173381Nexxis ORDXJ2018-02-22
2962021488723877K172612FiberTak DXMBI2017-09-28
2962021224093471K171296SutureTapeGAT2017-05-26
2962021899130158K170547Arthrex Mesh Plate SystemHRS2017-09-01
2962021035030731K170206Arthrex FiberTape CerclageJDQ2017-11-15
2962021607839547K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web PortalKWS2017-02-10
2962021335387532K161782Arthrex Univers Revers Shoulder Prosthesis SystemHSD2016-11-21
2962021664019313K161581Arthrex Synergy RF SystemGEI2016-09-09
2962021342083027K161108Arthrex VaultLock GlenoidKWS2016-08-29
2962021977969827K153513Insufflator 50L FM134HIF2016-03-04
2962021502380968K153218Arthrex Synergy UHD4 SystemGCJ2016-02-12
2962021527350284K151732Arthrex Fracture PlatesHRS2015-08-28
2962021929763876K151543Graft Delivery Device with Integrated StyletFMF2015-07-07
2962021266212086K151342Arthrex SwiveLock AnchorsMAI2016-03-24
2962021241393607K151256Arthrex BioSync® Bone WedgePLF2015-08-12
2962021089423870K151230Arthrex FiberTak AnchorsMBI2015-06-19
2962021407800843K151092Arthrex Short Suture AnchorsMBI2016-02-23
2962021777856083K151078Arthrex RetroFusion ScrewHWC2015-05-15
2962021058487816K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mmMBI2015-08-20
2962021860300877K150456Arthrex Plates, Screws, and StaplesHRS2015-04-29
2962021419379386K143749Arthrex Distal Radius SystemHRS2015-04-03
2962021394600963K143745Arthrex Corkscrew and SwiveLock Suture AnchorsMBI2015-07-02
2962021719236720K143702Arthrex Blunt Tip Screws with Fiber TapeHTY2015-04-09
2962021193547645K143614Arthrex Low Profile ScrewsHWC2015-01-16
2962021628979145K143139Arthrex Fracture SystemHRS2015-01-16
2962021772694788K142863Univers Rivers Shoulder Prosthesis SystemPHX2014-11-25
2962021057869136K141735ARTHREX ANKLE FUSION PLATING SYSTEMHRS2014-08-15
2962021355680668K141577ARTHREX PIP DARTHTY2014-07-18
2962021174836862K141478ARTHREX FRACTURE PLATES AND SCREWSHRS2014-07-08
2962021918508286K140855ARTHREX SUTURETAK SUTURE ANCHORSMAI2014-12-18
2962022046443797K133275MINI TIGHTROPEHTN2014-01-30
2962021732533838K132217ARTHREX COMPRESSION FT SCREWSHWC2013-11-25
2962021344277907K132043ARTHREX SPEEDCINCHGAT2013-07-31
2962021176882465K131474ARTHREX DISTAL RADIUS PLATE SYSTEMHRS2013-07-03
2962021505762157K130458KNOTLESS FIBERTAK SUTURE ANCHORMBI2013-05-03
2962021137450500K130129UNIVERS REVERS SHOULDER PROSTHESIS SYSTEMKWS2013-05-31
2962021940918789K123341ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTONMBI2012-12-21
2962021701196858K123241ARTHREX FRACTURE PLATESHRS2013-04-05
2962021547827721K122374ARTHREX SUTURE (UHMWPE)GAT2012-09-25
2962021532025402K121124ARTHREX MIXING AND DELIVERY SYSTEMFMF2012-05-16
2962021883210890K120155ARTHREX KNOTLESS SUTURETAK ANCHORMBI2012-02-17
2962021614707002K120044ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELEDKWS2012-03-08
2962021322981987K112990ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLEHTY2011-12-19
2962021700442493K112437ARTHREX FRACTURE SYSTEMHTN2011-12-21
2962021379357695K112237MICROSUTURE ANCHORSHWC2011-09-02
2962021890548818K111661ARTHREX SCAPHOLUNATE ANCHORMBI2011-08-19
2962021245165659K111253ARTHREX DISTAL EXTREMITY PLATE SYSTEMHRS2011-08-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI322023-11-15
HRS312022-10-03
MAI212022-08-26
HWC182022-09-19
HTN102022-08-22
HTY102020-06-29
GAT82021-10-25
KWS82017-02-10
GCJ62024-07-25
GEI42016-09-09
HRX42009-08-03
JDR32020-12-16
PHX32020-01-10
JDQ22023-08-24
HSB22022-12-20
FMF22015-07-07
PKC12020-07-08
QHQ12019-07-26
DXJ12018-02-22
HSD12016-11-21
HIF12016-03-04
PLF12015-08-12
KWD12007-01-03
EBW12001-02-07
HWE11994-01-25
KQM11988-08-04