FDA.report

SYNTHES GMBH / Synthes Produktions GmbH

Matched from indexed company URL: Synthes GmbH

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
80309653002807305SYNTHES GMBH / Synthes Produktions GmbH1N2026-01-01EIMATTSTRASSE 3 Oberdorf, Baselland Basel-Landschaft CH CH-4436
30038622133003862213Synthes GmbH (DE)1N2020-04-25IM KIRCHENHURSTLE 4 UMKIRCH B. FREIBURG Baden-Wurttemberg DE D-79224

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
10886982350435NA - HALF BENNETT SMALL/LEFT+1(800)255-2500xx@xx.xx
10886982350442NA - HALF BENNETT SMALL/RIGHT+1(800)255-2500xx@xx.xx
10886982350459NA - HALF BENNETT LARGE/LEFT+1(800)255-2500xx@xx.xx

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
238991690068075K191463DePuy Synthes Hammertoe Continuous Compression ImplantJDR2020-02-26
238991330732265K172157DePuy Synthes Femoral Recon Nail SystemHSB2017-11-14
238991648330408K170802TRAUMACEM™ V+ Injectable Bone CementLOD2017-09-28
238991604347892K150125Elite Nitinol Fixation SystemJDR2015-05-11
238991175100370K142292Speed, Speed Shift, Speed Titan, Speed ArcJDR2014-11-17
238991251664661K141385DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)HBW2015-03-27
238992057626004K133844SPEED TRIADJDR2014-04-07
238991376053505K133780SPEED XLJDR2014-03-19
238991696278656K133520HAMMERLOCK 2HTY2014-01-09
238992033243805K133270SPEED ARCJDR2014-04-17
238991192515482K124022SPEED SHIFTJDR2013-05-14
238991037401832K093361SYNTHES AIR PEN DRIVE (APD) SYSTEMHBB2010-04-14
238992016906453K090241SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)HSB2009-06-17
238991384313784K082649SYNTHES 90 DEGREE SCREWDRIVERDZI2009-04-30
238991706047565K073115ORTHOMESHHRS2008-07-15
238991239328540K062789SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEMJEY2007-02-27
238991314590173K053022SYNTHES (USA) CHRONOS-BETA-TCPLYC2006-01-23
238991827361250K043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMHWE2005-01-05
238991060585329K043045SYNTHES (USA) CHRONOSMQV2005-01-07
238991907109256K041611SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMPGXR2004-09-08
238991858966137K041350SYNTHES (USA) CHRONOSGXP2004-07-08
238991754928475K030069SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEMJEY2003-04-08
238991257557339K013072CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)MQV2002-11-26
239021028359701
238991028359701
239021088692173
239021120854028
239021177705032
238991187870261
239021215977125
239021296673711
239021318942853
238991318942853
238991346344141
239021361417786
239021390937177
239021419386299
239021689048885
238991728636194
238991880654424
239021883847913
238991999835921
238992040928085
238992041250727
239022066382498

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
JDR72020-02-26
HSB42017-11-14
JEY42007-02-27
MQV42005-01-07
LOD22017-09-28
HBW22015-03-27
HBB22010-04-14
DZI22009-04-30
HRS22008-07-15
LYC22006-01-23
HWE22005-01-05
GXR22004-09-08
GXP22004-07-08
HTY12014-01-09

PMN

GUDID

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