FDA.reportPublic FDA data

Arthrex (Shanghai) Co., Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30142626933014262693Arthrex (Shanghai) Co., Ltd.1N2026-01-012205-2208 Garden Square 968 Beijing West Road Shanghai CN 200041

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2962711370672514K943492ARTHREX STAPLESJDR1995-02-01
2962711943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
2962711635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
2962711859891543K243008Arthrex NanoScope SystemGCJ2025-01-22
2962711534704471K241361Arthrex Synergy Vision Endoscopic Imaging SystemGCJ2024-07-25
2962711673854296K241235Arthrex TightRope IIMBI2024-05-29
2962711655412181K233451Arthrex Synergy Vision Endoscopic Imaging SystemGCJ2024-01-18
2962711121776559K232973Arthrex Knee FiberTak® Button Suture AnchorMBI2023-11-15
2962711477854555K232755Arthrex FiberTape and TigerTape Cerclage SuturesHTN2023-10-06
2962711546046700K231330FiberTak® Suture AnchorMBI2023-06-01
2962711570822525K231113Arthrex FiberTak Suture AnchorMBI2023-05-18
2962711695834345K230568FiberTak Suture AnchorMBI2023-04-01
2962711765245744K222161Arthrex Knotless FiberTak Biceps Suture AnchorMBI2022-08-11
2962711310990545K222007Arthrex Virtual Implant Positioning (VIP) SystemQHE2023-03-08
2962711120566425K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWireMBI2022-09-07
2962711708862739K221485Arthrex FiberTape and TigerTape Cerclage SuturesHTN2022-08-22
2962711356488615K221396Arthrex FiberTak Suture AnchorMBI2022-12-22
2962711684588912K221099Arthrex Self-Punching PushLock Suture AnchorMAI2022-05-13
2962711729344289K203495Arthrex SwiveLock AnchorMAI2021-04-19
2962712059887981K203294Arthrex Pilon Fusion SystemHRS2021-02-03
2962711641866470K203268Arthrex FiberTak Suture AnchorMBI2020-11-27
2962711800369969K202581Arthrex TightRope IIMBI2020-11-04
2962712048636012K202535Arthrex FastThread Interference ScrewMAI2020-11-18
2962711112476228K201542Arthrex Eclipse Shoulder Prosthesis SystemPKC2020-07-08
2962711127854339K201132Arthrex Compression ScrewsHRS2020-07-27
2962711677870257K200341Arthrex FiberTak Suture AnchorMBI2020-03-12
2962711658902892K193157Arthrex 3.9mm Corkscrew Suture AnchorMAI2019-12-12
2962711220515949K191226Arthrex SwiveLock Suture AnchorMAI2019-06-11
2962711416729640K183194Arthrex Eclipse Shoulder Prosthesis SystemQHQ2019-07-26
2962711202533516K181769Arthrex FiberTak Suture AnchorMBI2018-09-21
2962712056430873K180662Arthrex FastThread Interference ScrewMAI2018-05-22
2962711329878334K180594Knotless SutureTak AnchorsMAI2018-06-22
2962712044871540K180118Arthrex NanoSuture AnchorMBI2018-02-12
2962711335834251K173900Arthrex Univers Revers Modular Glenoid SystemPHX2018-04-20
2962711488723877K172612FiberTak DXMBI2017-09-28
2962711899130158K170547Arthrex Mesh Plate SystemHRS2017-09-01
2962711607839547K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web PortalKWS2017-02-10
2962711335387532K161782Arthrex Univers Revers Shoulder Prosthesis SystemHSD2016-11-21
2962711664019313K161581Arthrex Synergy RF SystemGEI2016-09-09
2962711342083027K161108Arthrex VaultLock GlenoidKWS2016-08-29
2962711502380968K153218Arthrex Synergy UHD4 SystemGCJ2016-02-12
2962711821486538K151527Arthrex Univers Revers CA Heads and AdaptersHSD2016-04-19
2962711266212086K151342Arthrex SwiveLock AnchorsMAI2016-03-24
2962711089423870K151230Arthrex FiberTak AnchorsMBI2015-06-19
2962711407800843K151092Arthrex Short Suture AnchorsMBI2016-02-23
2962711860300877K150456Arthrex Plates, Screws, and StaplesHRS2015-04-29
2962711394600963K143745Arthrex Corkscrew and SwiveLock Suture AnchorsMBI2015-07-02
2962711193547645K143614Arthrex Low Profile ScrewsHWC2015-01-16
2962711772694788K142863Univers Rivers Shoulder Prosthesis SystemPHX2014-11-25
2962711057869136K141735ARTHREX ANKLE FUSION PLATING SYSTEMHRS2014-08-15
2962711174836862K141478ARTHREX FRACTURE PLATES AND SCREWSHRS2014-07-08
2962711918508286K140855ARTHREX SUTURETAK SUTURE ANCHORSMAI2014-12-18
2962712046443797K133275MINI TIGHTROPEHTN2014-01-30
2962711732533838K132217ARTHREX COMPRESSION FT SCREWSHWC2013-11-25
2962711344277907K132043ARTHREX SPEEDCINCHGAT2013-07-31
2962711176882465K131474ARTHREX DISTAL RADIUS PLATE SYSTEMHRS2013-07-03
2962711505762157K130458KNOTLESS FIBERTAK SUTURE ANCHORMBI2013-05-03
2962711940918789K123341ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTONMBI2012-12-21
2962711701196858K123241ARTHREX FRACTURE PLATESHRS2013-04-05
2962711547827721K122374ARTHREX SUTURE (UHMWPE)GAT2012-09-25
2962711532025402K121124ARTHREX MIXING AND DELIVERY SYSTEMFMF2012-05-16
2962711322981987K112990ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLEHTY2011-12-19
2962711379357695K112237MICROSUTURE ANCHORSHWC2011-09-02
2962711953352889K112040ARTHREX BIOCOMPOSITE TRANSFIXMAI2011-12-15
2962711245165659K111253ARTHREX DISTAL EXTREMITY PLATE SYSTEMHRS2011-08-02
2962711381765463K110660ARTHREX BIOCOMPOSITE SUTURETAKMAI2011-03-31
2962711198919747K110123PCL TIGHTROPEHTY2011-04-28
2962711234502965K103705LOW PROFILE SCREWSHWC2011-03-18
2962711991797874K103060ARTHREX TIBIAL GRAFTBOLTMBI2011-01-05
2962711309552333K101837ACL TIGHTROPE DOUBLE BUNDLEHTY2010-12-28
2962711404419440K101823ARTHREX SWIVELOCK ANCHORSMAI2011-01-07
2962711056593767K101679ARTHREX PUSHLOCK ANCHORSMAI2010-10-22
2962711641939908K100652ACL TIGHTROPEHTY2010-06-23
2962711794093700K093912ARTHREX TIBIAL GRAFTBOLTMBI2010-03-18
2962711635503371K091844ARTHREX BIO-COMPOSITE SUTURETAK ANCHORSMAI2009-08-28
2962711053522637K090107MINI TIGHTROPEHTN2009-08-06
2962711694342628K083707ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICEHRX2009-08-03
2962711558252275K082810ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREWMAI2009-01-23
2962711015150221K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEHRX2008-03-18
2962712023594562K080111ARTHREX COMPRESSION STAPLEJDR2008-02-13
2962711887136300K073149MENISCAL CINCHGAT2008-02-11
2962711118173825K071756ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTUREGCJ2007-08-15
2962711454007827K071176MODIFICATION TO: ARTHREX INTERFERENCE SCREWMAI2007-08-03
2962711103054165K071032ARTHREX UNIVERS II SHOULDER PROSTHESISKWS2007-08-20
2962711475982281K063479ARTHREX PUSHLOCKHWC2006-12-13
2962711089927657K062747ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MMHRS2006-09-29
2962711978667268K062466ARTHREX INTERFERENCE SCREWMAI2006-11-29
2962711158340470K061863ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILYHWC2006-10-19
2962711179179647K053510IR WIRELESS FOOT SWITCHGEI2006-03-20
2962711818955615K053338ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTSHWC2006-01-26
2962712019525600K052776TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBDHTN2005-12-13
2962711242751167K052736ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XTHTY2005-11-03
2962712018495756K052614LOW PROFILE PLATE AND SCREW SYSTEMHRS2005-09-28
2962711063008414K051726ARTHREX TENODESIS FAMILYHWC2005-09-27
2962711617331402K050749ARTHREX TAK FAMILYHWC2005-05-12
2962711828708923K043248TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DSHTN2005-02-16
2962712036876328K041553ARTHREX SUTURE GRAFTING KITGAT2004-12-10
2962711322534300K032187ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEMHRS2003-09-22
2962711809540857K024291ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475HRX2003-03-20
2962711767426967K021434ARTHREX FIBERWIRE IN USP SIZESGAT2002-11-07
2962711257612176BK210655
2962711525233049BK180299
2962711359836396BK070069
2962711034045755
2962711161084072
2962711192375044
2962711237667726
2962711267391307
2962711271608110
2962711353211118
2962711369543475
2962711409456947
2962711441412956
2962711704576765
2962711715601290
2962712006747056
2962712012111779

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI212024-05-29
MAI172022-05-13
HRS122021-02-03
HWC92015-01-16
GCJ62025-01-22
HTN62023-10-06
GAT52013-07-31
HTY52011-12-19
KWS32017-02-10
HRX32009-08-03
PHX22018-04-20
HSD22016-11-21
GEI22016-09-09
JDR22008-02-13
QHE12023-03-08
PKC12020-07-08
QHQ12019-07-26
FMF12012-05-16
HWE11994-01-25