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SYNTHES GMBH / Synthes Produktions GmbH

Matched from indexed company URL: Synthes GmbH

FDA Registration(s)#

Registration, FEI, Name table
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 GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10705034717081Zero-P - ZERO-P TRIAL SPACER/CONVEX LARGE/12MM HEIGHT+1(800)255-2500xx@xx.xx
10705034717098Zero-P - ZERO-P TRIAL SPACER/CONVEX LARGE/5MM HEIGHT+1(800)255-2500xx@xx.xx
10705034717203NA - SCREW INSERTER T8-QC SELF-RETAINING/HIGH STRENGTH+1(800)255-2500xx@xx.xx
10705034722634NA - VERTEBRAL AUGMENTATION ACCESS KIT+1(800)255-2500xx@xx.xx
10705034731841NA - MILLING BIT WITH FLAT COUPLING-STERILE+1(800)255-2500xx@xx.xx
10705034736075USS - 6.2MM TI USS POLYAXIAL SCREW 60MM THREAD LENGTH+1(800)255-2500xx@xx.xx
10705034742199Zero-P - ZERO-P IMPLANT 12MM HEIGHT CONVEX/LARGE-STERILE+1(800)255-2500xx@xx.xx
10886982228185NA - 12MM/125 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER+1(800)255-2500xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
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 code, Registration listing records, Latest decision table
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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