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ARTHROSURFACE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041543143004154314ARTHROSURFACE, INC.1N2026-01-01319 Manley St W Bridgewater MA US 02379

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
624381281641631K203375OVOMotion Reverse Shoulder Arthroplasty SystemPHX2021-06-24
624382063357824K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemJWJ2020-10-15
624381916007224K190261BOSS Toe Fixation SystemKWD2019-08-14
624381358206493K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemKRR2018-06-14
624381732493656K173964OVOMotion Shoulder Arthroplasty SystemHSD2018-04-18
624381072363484K172383Arthrosurface Bone ScrewsHWC2017-12-22
624381944943813K170440KISSloc Suture SystemHTN2017-05-03
624381746814128K170350ToeMATE® Hammertoe Correction SystemHWC2017-03-03
624381971392958K162391AlignMATE™ Lapidus Arthrodesis SystemHRS2017-02-21
624381664773260K161539Arthrosurface Bone ScrewsHWC2016-06-30
624381926290046K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemKWD2016-04-11
624381854407681K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemHSD2014-12-19
624381197023913K141920Wrist Hemiarthroplasty SystemKWN2014-12-23
624381752839484K133835ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEMHTN2014-07-03
624381197983761K132496ARTHROSURFACE TOEMOTIONLZJ2014-02-26
624381864395447K131377HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTKWD2013-11-19
624381208516017K130859HAMMERTOE CORRECTION SYSTEMHWC2013-07-25
624381455005349K122334CHECKMATE SMALL BONE FUSION SYSTEMHRS2012-11-28
624381438899635K113762CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEMHRS2012-02-06
624381521090625K091196GRS GLENOID RESURFACING SYSTEMKWS2009-10-27
624381773449111K071413HEMICAP PATELLO-FEMORAL RESURFACING SYSTEMKRR2007-11-09
624381837036021K063370CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTYKWD2007-01-12
624381453373145K060127HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESISKRR2006-03-16
624381170544478K050373UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESISHSX2005-10-11
624381955043062K031859CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANTKWD2004-02-18
624381707579544K023096CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEMHSD2003-04-10
624381003175735K021549CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEMKXA2002-08-01
624381873253687
624381204771493
624381626689195
624381866083271
624381971041457

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWD52019-08-14
HWC42017-12-22
KRR32018-06-14
HSD32018-04-18
HRS32017-02-21
HTN22017-05-03
PHX12021-06-24
JWJ12020-10-15
KWN12014-12-23
LZJ12014-02-26
KWS12009-10-27
HSX12005-10-11
KXA12002-08-01

PMN#

GUDID#

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