FDA.report

Arthrex Manufacturing Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30152317893015231789Arthrex Manufacturing Inc.1N2026-01-01130 Arthrex Drive Pendleton SC US 29670

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2333621213657564K991971ARTHREX CHONDRAL DART, MODEL AR-4005B-18HTY2000-08-04
2333621172069684K990987BIO-ABSORBABLE CORKSCREW, MODEL AR-1920BMAI2000-01-13
2333621526523718K983577ARTHREX MENISCAL DART SYSTEMMAI1999-08-13
2333621329191466K981187ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001HWC1998-07-01
2333621803359182K9748475.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235MBI1998-08-06
2333621312915195K973812ARTHREX PUDDU OSTEOTOMY SYSTEMHRS1998-06-10
2333621196806715K971723FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)MBI1997-07-30
2333621232689819K971358BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MMMAI1997-07-09
2333621753137371K960516FASTAK SUTURE ANCHORMBI1996-04-18
2333621645285625K945426ARTHREX CANCELLOUS SCREW AND WASHERHWC1995-04-14
2333621440578319K945303ARTHREX BIOABSORBABLE INTERFERENCE SCREWHWC1996-01-25
2333621044046155K934327ARTHREX SUTURE ANCHOR SCREW SYSTEMMBI1995-09-15
2333621760716052K193503Arthrex SwiveLock Suture AnchorMAI2020-01-15
2333621581053510K190645Arthrex NanoScope SystemGCJ2019-07-05
2333621784543545K183628Arthrex TensionLoc SystemHWC2019-03-26
2333621416729640K183194Arthrex Eclipse Shoulder Prosthesis SystemQHQ2019-07-26
2333621234466108K182361Arthrex Compression FT ScrewsHWC2018-12-18
2333621777769153K181513Arthrex PushLock Tenodesis AnchorMBI2018-08-30
2333621769392760K180768Arthrex SwiveLock AnchorsMAI2018-12-14
2333622044871540K180118Arthrex NanoSuture AnchorMBI2018-02-12
2333621005367378K173845Arthrex SwiveLockMBI2018-08-06
2333621678633281K173788Arthrex Corkscrew FTMAI2018-03-01
2333621043499957K172371Arthrex UNIVERS REVERS COATED BASEPLATEPHX2018-03-22
2333621310879820K171841Arthrex Shoulder SystemKWS2018-03-29
2333621865469897K171020Arthrex Knotless SutureTak AnchorMBI2017-05-16
2333622039112265K170414Arthrex Univers Revers Apex Humeral StemsPHX2017-12-14
2333622059197007K170382Arthrex Compression ScrewsHWC2017-05-11
2333621607839547K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web PortalKWS2017-02-10
2333621039636825K161371Sonoma Fifth Metatarsal Repair SystemHSB2017-02-24
2333621166566984K161060Arthrex iBalance UKA System Vitamin E Tibial BearingHSX2016-12-15
2333621113239248K160319FiberTak DRMBI2016-05-10
2333621976485386K153612ArthrexVIP Web PortalLLZ2016-03-15
2333621155758979K153586Arthrex iBalance TKA SystemMBH2016-02-19
2333621801376057K153215SmartBase for Arthrex Glenoid IRISKWS2016-02-19
2333621228648472K153115Arthrex Univers Apex, Size 5 StemKWS2015-11-23
2333621263649672K152252Arthrex iBalance TKA SystemMBH2015-11-16
2333621499477749K151568Arthrex OrthoVis Preoperative PlanLLZ2015-07-31
2333621089694286K151501OrthoVis Web PortalLLZ2015-10-02
2333621543282183K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)KWS2015-10-05
2333621117815871K150376Sonoma Cancellous Bone Screw and WasherHWC2015-06-12
2333621419379386K143749Arthrex Distal Radius SystemHRS2015-04-03
2333621719236720K143702Arthrex Blunt Tip Screws with Fiber TapeHTY2015-04-09
2333621240192659K143047Arthrex iBalance Patella Implant, DomeJWH2014-11-19
2333621086890887K142945Sonoma Fibula Repair SystemHSB2015-01-22
2333621672475079K142072GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)KWS2014-11-24
2333621374444501K140476ARTHREX FIBERTAK SUTURE ANCHORMBI2014-08-13
2333621965354893K140019ARTHREX BIOSUTUREGAT2014-01-30
2333621472925301K133854ARTHREX IBALANCE TKA SYSTEMJWH2014-02-27
2333621588684227K133367ORTHOVIS PREOPERATIVE PLANLLZ2013-12-20
2333622058975393K133342ARTHREX IBALANCE TKA SYSTEMJWH2013-12-17
2333622036529372K130675ARTHREX UNIVERS II CA HEADSHSD2013-10-30
2333621470287777K130510ARTHREX COMPRESSION PLATESHRS2013-09-25
2333621505762157K130458KNOTLESS FIBERTAK SUTURE ANCHORMBI2013-05-03
2333621501137219K123122GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)KWS2013-04-05
2333621179669541K121494LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPINGHRS2012-11-19
2333621598278480K120540BIOBOLTMAI2012-03-20
2333621883210890K120155ARTHREX KNOTLESS SUTURETAK ANCHORMBI2012-02-17
2333621043697240K113652LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF THRS2012-08-30
2333621267505799K113601AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEMHRS2012-11-08
2333621889472976K112899ARTHREX BIO-SUTUREGAT2012-04-06
2333621538311304K111550SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)HSB2011-08-19
2333621381765463K110660ARTHREX BIOCOMPOSITE SUTURETAKMAI2011-03-31
2333621142207026K103036ALLOFUSE PLUSMQV2011-01-10
2333621711965104K101032CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRXJWH2010-07-08
2333621064455795K100112SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)HSB2010-09-28
2333621034039984K092803CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENTJWH2009-12-23
2333621982165780K092110WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)HSB2010-01-20
2333621649071234K091018ARTHREX BIOWIREGAS2010-07-30
2333621446897484K090304WAVEON WRX BONE FIXATION SYSTEMHRS2009-08-28
2333621053522637K090107MINI TIGHTROPEHTN2009-08-06
2333621657103373K081832ENSPLINTCMX CLAVICLE PINHSB2008-10-10
2333622061101863K081127ACCIN TOTAL KNEE SYSTEMJWH2008-10-17
2333621582399643K080778ENSPLINT TM BONE SCREWHWC2008-07-10
2333621887136300K073149MENISCAL CINCHGAT2008-02-11
2333621949688361K073120ACCIN PATELLOFEMORAL SYSTEMKRR2008-02-29
2333621261800240K072411AAP BONE PLATES AND SCREW IMPLANTSHRS2008-03-20
2333621061878034K071852AAP APS SYSTEMKTT2007-08-29
2333621354136972K071809ENSPLINTRX BONE FIXATION SYSTEMHRS2008-02-21
2333621999220130K071622ARTHREX FIBERWIREGAT2007-07-03
2333621312995926K071456ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANTMAI2008-01-17
2333621434190772K071177ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREWHWC2007-06-29
2333621382678940K063782ACCIN UNI-KNEE SYSTEMHSX2007-01-19
2333621642552544K063719ARTHREX CROSSPIN, MODEL AR-1964PHTY2007-03-06
2333621728249309K062679ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURESHWC2006-09-27
2333621587995114K061925MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DSHTN2006-10-31
2333621087733673K061665ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FTHWC2006-07-25
2333621415949283K061499OSFERIONMQV2007-01-26
2333621774529572K060670ACCIN UNI-KNEE SYSTEMHSX2006-06-02
2333621818955615K053338ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTSHWC2006-01-26
2333621728671856K052901ARTHREX TENSIONLOKHRS2005-12-12
2333621430030797K052607ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWSHWC2005-11-07
2333621389807133K051219PUSHLOCKMAI2005-06-29
2333621617331402K050749ARTHREX TAK FAMILYHWC2005-05-12
2333621305959784K050634MODIFICATION TO: ARTHREX V-TAKHWC2005-03-21
2333621313573020K050358ARTHERX CORKSCREW FT II SUTURE ANCHORHWC2005-04-15
2333621459059976K043145BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367BHTN2005-02-18
2333621260151962K041589ARTHREX FIBERWIRE WITH SILKGAT2004-08-05
2333622002225953K041356ARTHREX TENODESIS SCREW FAMILYHWC2004-11-04
2333621382533468K040907ARTHREX SMALL FRAGMENT PLATES AND SCREWSHRS2004-07-01
2333621120597490K032245ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239GAT2004-01-14
2333621247918768K032098ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025BHWC2003-10-07
2333621800066938K031945ARTHREX TRIMIT SCREW, MODEL AR-4161BHWC2003-09-22
2333621870300229K031666ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DSHRS2003-11-18
2333621530495783K023119BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367BHTN2002-12-18
2333621767426967K021434ARTHREX FIBERWIRE IN USP SIZESGAT2002-11-07
2333621264842837K0200434.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555BHWC2002-04-02
2333621515207972K014155OPENING/CLOSING WEDGE OSTETOMY PLATESHRS2002-03-18
2333621434230776K012923ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201GAT2001-10-04
2333621400824737K011172ARTHREX BIO-TRANSFIXMNU2001-06-19
2333621816596973K011007TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55MBI2001-06-12
2333621013587498K010673ARTHREX FIBERWIRE, MODEL SPU-02NB-3800GAT2001-05-14
2333621495880829K010525ARTHREX TENODESIS SCREW 7MM, 8MM, 9MMHWC2001-05-23
2333621732115809K003816ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MMHWC2001-03-09
2333621519432233K000506BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324BMAI2000-05-01
2333621089152312
2333621345239411
2333621415944597
2333621600816996
2333621607743040
2333621627291403

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HWC222019-03-26
MBI132018-08-30
HRS132015-04-03
MAI112020-01-15
GAT92014-01-30
KWS72018-03-29
HSB62017-02-24
JWH62014-11-19
LLZ42016-03-15
HTN42009-08-06
HSX32016-12-15
HTY32015-04-09
PHX22018-03-22
MBH22016-02-19
MQV22011-01-10
QHQ12019-07-26
GCJ12019-07-05
HSD12013-10-30
GAS12010-07-30
KRR12008-02-29
KTT12007-08-29
MNU12001-06-19