FDA.report

FH INDUSTRIE

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30038982283003898228FH INDUSTRIE1N2026-01-01ZI DE KERNEVEZ-6 RUE NOBEL QUIMPER Finistere FR 29000

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
164001028042692K964878ESOP S/C FEMORAL STEMMEH1998-03-05
164001630072190K961388ATLAS III ACETABULAR CUPMEH1997-04-03
164001933779694K254003JARVIS Metaphyseal StemPHX2026-01-09
164001744711967K253345JARVIS Diaphyseal Stem StandardPHX2025-10-29
164001340337885K252411JARVIS Glenoid Reverse Shoulder ProsthesisPHX2025-08-28
164001976120739K242253JARVIS Glenoid Reverse Shoulder ProsthesisPHX2024-11-25
164001774625219K232226ARROW Off-Centred Humeral InsertPHX2023-08-29
164001687671378K220758e-Ortho Shoulder Software v1.1LLZ2022-09-30
164001950981249K202024ARROW Short Stem Humeral SystemPHX2021-11-30
164001418078443K201928e-Ortho Shoulder SoftwareLLZ2020-09-30
164001550282822K200127TELEGRAPH® EVOLUTION Humeral Nailing SystemHSB2020-10-01
164001525491416K171789ARROW Reverse Porous GlenoidPHX2018-01-23
164001371520613K170040BePOD Cannulated Arthrodesis ScrewsHWC2017-04-04
164001850198694K163710BePOD® EZ Weil ScrewsHWC2017-09-08
164001521586549K163148BePOD® Foot ScrewsHWC2017-09-14
164001976307027K162068ARROW Anatomical Porous glenoidMBF2017-04-10
164001722711863K150568ARROW Humeral stems size 6 and 16PHX2015-10-29
164001370931935K150471CalcaNail Orthopedic Arthrodesis NailHSB2015-05-22
164001571615246K150463CalcaNail Orthopedic NailHSB2015-05-22
164001686318119K142778ARROW Reverse Shoulder long keel and short keel glenoid basePHX2015-03-20
164002019860235K120740COLS® FIXATION SYSTEMMBI2013-03-05
164001507394101K113591COLS PEEKHWC2011-12-22
164001018014393K112193ARROW REVERSE SHOULDER SYSTEMPHX2012-07-12
164001592213261K093599ARROW ANATOMICAL SHOULDER SYSTEMKWS2010-11-24
164001298436539K070617CANNULATED SCREWHWC2007-06-14
164001276660087K060367TENOLIGGAT2006-08-09
164001177600844K052058MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAILHSB2005-08-22
164001860507062K042332TITANIUM TELEGRAPH HUMERAL NAILHSB2004-10-07
164001463390495K042035ALUMINA HEADLZO2004-11-17
164001430262089K033510MODIFICATION TO TELEGRAPH HUMERAL NAILHSB2003-12-03
164001330261169K023375MODIFICATION TO ESOP CO-CR FEMORAL HEADSLPH2002-10-25
164001535032326K023241TELEGRAPH HUMERAL NAILHSB2002-12-24
164001207518307K021109ESOP CO-CR FEMORAL HEADSLPH2002-06-12
164001921893301K021108ESOP HA FEMORAL STEMMEH2002-05-03
164001582811656
164001809478515

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
PHX102026-01-09
HSB72020-10-01
HWC52017-09-14
MEH32002-05-03
LLZ22022-09-30
LPH22002-10-25
MBF12017-04-10
MBI12013-03-05
KWS12010-11-24
GAT12006-08-09
LZO12004-11-17

PMN