FDA.reportPublic FDA data

Arthrex Singapore Pte Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30140043493014004349Arthrex Singapore Pte Ltd.1N2026-01-0121 Biopolis Road Nucleos North Tower Unit 03-08 Singapore Central Singapore SG 138567

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2963131496666919K983843BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238BMAI1999-03-12
2963131415905884K982743DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBHGEI1998-09-14
2963131196806715K971723FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)MBI1997-07-30
2963131370672514K943492ARTHREX STAPLESJDR1995-02-01
2963131943372863K941541HSV LAPAROSCOPY SETGCJ1994-05-16
2963131635148370K932699ARTHREX AR-8200 SHAVER SYSTEMHWE1994-01-25
2963131173826867K921119ARTHREX ARTHROSCOPEHRX1994-04-15
2963131512532981K915721MODEL AR-6300 INFUSION PUMPHRX1992-03-19
2963131666311898K915424ARTHREX CANNULATED INTERFERENCE SCREWHWC1993-02-09
2963131235537325K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
2963131534704471K241361Arthrex Synergy Vision Endoscopic Imaging SystemGCJ2024-07-25
2963131673854296K241235Arthrex TightRope IIMBI2024-05-29
2963131121776559K232973Arthrex Knee FiberTak® Button Suture AnchorMBI2023-11-15
2963131477854555K232755Arthrex FiberTape and TigerTape Cerclage SuturesHTN2023-10-06
2963132055837088K232742Arthrex FiberTak Suture AnchorMBI2023-11-03
2963131546046700K231330FiberTak® Suture AnchorMBI2023-06-01
2963131570822525K231113Arthrex FiberTak Suture AnchorMBI2023-05-18
2963131242851426K230976Arthrex Radiopaque FiberTape Cerclage suturesJDQ2023-08-24
2963131695834345K230568FiberTak Suture AnchorMBI2023-04-01
2963131044870499K230435Arthrex 3.9 mm SwiveLock AnchorMAI2023-03-17
2963131440889354K230433Arthrex Knotless FiberTak Suture AnchorMBI2023-03-10
2963131578407023K230366Arthrex Univers Revers Monoblock Stem Size 4/33PHX2023-04-10
2963131768161671K223284SutureLoc™ ImplantMBI2023-02-02
2963131650670333K222263Arthrex Self Punching SwiveLock Suture AnchorsMAI2022-08-26
2963131765245744K222161Arthrex Knotless FiberTak Biceps Suture AnchorMBI2022-08-11
2963131310990545K222007Arthrex Virtual Implant Positioning (VIP) SystemQHE2023-03-08
2963131120566425K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWireMBI2022-09-07
2963131708862739K221485Arthrex FiberTape and TigerTape Cerclage SuturesHTN2022-08-22
2963131356488615K221396Arthrex FiberTak Suture AnchorMBI2022-12-22
2963131388585094K221232Univers Revers Humeral Cup ImplantHSD2022-05-19
2963131684588912K221099Arthrex Self-Punching PushLock Suture AnchorMAI2022-05-13
2963131719519637K220947Arthrex Knotless AC Repair DevicesHTN2022-06-06
2963131637842578K220937Arthrex Mini Fragment SystemHRS2022-06-29
2963131586216255K213644Arthrex Knotless Mini TightRopesHTN2021-12-17
2963132052033385K210994Arthrex Beveled FT ScrewsHWC2021-06-01
2963131264043169K210050Augmented VaultLock GlenoidKWS2021-06-07
2963131729344289K203495Arthrex SwiveLock AnchorMAI2021-04-19
2963132059887981K203294Arthrex Pilon Fusion SystemHRS2021-02-03
2963131641866470K203268Arthrex FiberTak Suture AnchorMBI2020-11-27
2963131012772476K203239Arthrex Low Profile ScrewsHWC2020-12-30
2963131737370116K203180Arthrex DynaNite Nitinol StaplesJDR2020-12-16
2963131816684943K202582Arthrex SynergyID Endoscopic Imaging SystemGCJ2021-07-22
2963131800369969K202581Arthrex TightRope IIMBI2020-11-04
2963132048636012K202535Arthrex FastThread Interference ScrewMAI2020-11-18
2963131567733028K202444Knotless TensionTight Button Implant SystemMBI2020-11-17
2963131415780078K201749Arthrex SwiveLock AnchorMAI2020-08-21
2963131233418372K201677Arthrex Mesh PlatesHRS2020-09-02
2963131112476228K201542Arthrex Eclipse Shoulder Prosthesis SystemPKC2020-07-08
2963132002253262K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemHTN2020-09-03
2963131327473572K201235Arthrex MaxForce MTP Compression Plates and ScrewsHRS2020-07-06
2963131064571647K201134Arthrex NanoScope SystemGCJ2020-09-04
2963131127854339K201132Arthrex Compression ScrewsHRS2020-07-27
2963131590923911K200895Univers Revers Modular Glenoid System, Half Augment BaseplatePHX2020-08-13
2963131677870257K200341Arthrex FiberTak Suture AnchorMBI2020-03-12
2963131264856128K200068Arthrex DynaNite K-WireHTY2020-06-29
2963131895565053K193575Arthrex SutureTapeGAT2020-07-24
2963131760716052K193503Arthrex SwiveLock Suture AnchorMAI2020-01-15
2963131617796149K193372Univers Revers Modular Glenoid System (Augemented baseplates)PHX2020-01-10
2963131663630021K193345Arthrex DynaNite Compression PlateHRS2020-07-08
2963131658902892K193157Arthrex 3.9mm Corkscrew Suture AnchorMAI2019-12-12
2963131087212927K193156Arthrex Mini Comprehensive Fixation System - 1.0mm ScrewsHWC2020-02-10
2963131747445400K191651Arthrex Nano SwiveLock Suture AnchorHWC2019-11-06
2963131624813494K191426FiberTak ButtonMBI2019-11-26
2963131556267380K191344Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm ModuleHRS2019-10-03
2963132029854750K191326Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm ModuleHRS2019-10-15
2963131220515949K191226Arthrex SwiveLock Suture AnchorMAI2019-06-11
2963131716679293K190287Arthrex DynaNite® PIP (Hammertoe) ImplantHTY2019-05-03
2963131784543545K183628Arthrex TensionLoc SystemHWC2019-03-26
2963131176519828K183395Arthrex 2.5 mm Tenodesis ScrewHWC2019-04-17
2963131416729640K183194Arthrex Eclipse Shoulder Prosthesis SystemQHQ2019-07-26
2963131202533516K181769Arthrex FiberTak Suture AnchorMBI2018-09-21
2963131493062547K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisKWS2018-12-21
2963132056430873K180662Arthrex FastThread Interference ScrewMAI2018-05-22
2963131329878334K180594Knotless SutureTak AnchorsMAI2018-06-22
2963131874538785K180533Procellera Composite Antibacterial Wound DressingFRO2018-12-10
2963132044871540K180118Arthrex NanoSuture AnchorMBI2018-02-12
2963131335834251K173900Arthrex Univers Revers Modular Glenoid SystemPHX2018-04-20
2963131678633281K173788Arthrex Corkscrew FTMAI2018-03-01
2963131536282979K173656Arthrex FibuLock NailHSB2018-07-26
2963131316114438K173240Arthrex PushLockMAI2018-01-16
2963131488723877K172612FiberTak DXMBI2017-09-28
2963132018011279K171869Sutter CURIS RF GeneratorGEI2018-02-23
2963131224093471K171296SutureTapeGAT2017-05-26
2963132039112265K170414Arthrex Univers Revers Apex Humeral StemsPHX2017-12-14
2963131035030731K170206Arthrex FiberTape CerclageJDQ2017-11-15
2963131607839547K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web PortalKWS2017-02-10
2963131335387532K161782Arthrex Univers Revers Shoulder Prosthesis SystemHSD2016-11-21
2963131664019313K161581Arthrex Synergy RF SystemGEI2016-09-09
2963131342083027K161108Arthrex VaultLock GlenoidKWS2016-08-29
2963131502380968K153218Arthrex Synergy UHD4 SystemGCJ2016-02-12
2963131527350284K151732Arthrex Fracture PlatesHRS2015-08-28
2963131929763876K151543Graft Delivery Device with Integrated StyletFMF2015-07-07
2963131821486538K151527Arthrex Univers Revers CA Heads and AdaptersHSD2016-04-19
2963131266212086K151342Arthrex SwiveLock AnchorsMAI2016-03-24
2963131241393607K151256Arthrex BioSync® Bone WedgePLF2015-08-12
2963131089423870K151230Arthrex FiberTak AnchorsMBI2015-06-19
2963131777856083K151078Arthrex RetroFusion ScrewHWC2015-05-15
2963131058487816K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mmMBI2015-08-20
2963131860300877K150456Arthrex Plates, Screws, and StaplesHRS2015-04-29
2963131419379386K143749Arthrex Distal Radius SystemHRS2015-04-03
2963131394600963K143745Arthrex Corkscrew and SwiveLock Suture AnchorsMBI2015-07-02
2963131719236720K143702Arthrex Blunt Tip Screws with Fiber TapeHTY2015-04-09
2963131193547645K143614Arthrex Low Profile ScrewsHWC2015-01-16
2963131772694788K142863Univers Rivers Shoulder Prosthesis SystemPHX2014-11-25
2963131057869136K141735ARTHREX ANKLE FUSION PLATING SYSTEMHRS2014-08-15
2963131355680668K141577ARTHREX PIP DARTHTY2014-07-18
2963131174836862K141478ARTHREX FRACTURE PLATES AND SCREWSHRS2014-07-08
2963131918508286K140855ARTHREX SUTURETAK SUTURE ANCHORSMAI2014-12-18
2963131263606149K140328CMC MINI TIGHTROPEHTN2014-03-10
2963131965354893K140019ARTHREX BIOSUTUREGAT2014-01-30
2963131732533838K132217ARTHREX COMPRESSION FT SCREWSHWC2013-11-25
2963131799940458K131633ARTHREX UNIVERS APEXKWS2013-09-27
2963131176882465K131474ARTHREX DISTAL RADIUS PLATE SYSTEMHRS2013-07-03
2963131984404142K131157RANFAC BONE MARROW ASPIRATION NEEDLEKNW2013-10-22
2963131586502081K130778DISCOSCOPES, CERVICAL ENDOSCOPESHRX2014-04-14
2963131505762157K130458KNOTLESS FIBERTAK SUTURE ANCHORMBI2013-05-03
2963131137450500K130129UNIVERS REVERS SHOULDER PROSTHESIS SYSTEMKWS2013-05-31
2963131940918789K123341ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTONMBI2012-12-21
2963131701196858K123241ARTHREX FRACTURE PLATESHRS2013-04-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI292024-05-29
MAI272023-03-17
HRS232022-06-29
HWC202021-06-01
HTN122023-10-06
HTY92020-06-29
KWS82021-06-07
GCJ62024-07-25
PHX62023-04-10
GAT62020-07-24
HRX62014-04-14
GEI52018-02-23
HSD32022-05-19
JDR32020-12-16
FMF32015-07-07
JDQ22023-08-24
MQV22008-05-02
EBW22002-05-03
QHE12023-03-08
PKC12020-07-08
QHQ12019-07-26
FRO12018-12-10
HSB12018-07-26
PLF12015-08-12
KNW12013-10-22
KWD12007-01-03
LZB12005-11-29
HWE11994-01-25
FST11990-04-23