FDA.reportPublic FDA data

Synthes Produktions GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96124883002807651Synthes Produktions GmbH1N2020-04-25MURACHERSTRASSE 3 BETTLACH Solothurn CH 2544
30038753593003875359Synthes Produktions GmbH1N2020-04-25IM BIFANG HAGENDORF Solothurn CH CH-4614
30061260833006126083Synthes Produktions GmbH1N2020-04-25Kanalstrasse West 30 Raron Valais CH CH3942
30094508843009450884Synthes Produktions GmbH1N2020-04-25Solothurnerstrasse 186 Grenchen Solothurn CH CH2540

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
239011100181742K993314SYNTHES LIGHT GUIDEFQP1999-12-06
1301051822073355K974908SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATESHRS1998-03-18
1301051250702500K974537SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEMKTT1998-02-18
238981543106612K973018SYNTHES MINI LENGTHENING APPARATUSMQN1997-11-10
238981852277158K971987SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORJEY1997-06-24
1300991158691296K963618SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)LXT1996-11-12
1301051241587245K963325SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEMHRS1997-03-25
1301051053936220K963172SYNTHES STERILE 4.5 MM CANNULATED SCREWSHWC1996-11-08
1301051556319827K962894SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEMHRS1996-12-17
1301051115203201K962616SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEMHRS1996-09-03
239011254603165K962608SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTORMNH1996-12-09
1301051353440751K962047TITANIUM CANNULATED TIBIAL NAIL (TI CTN)JDS1996-07-24
1301051225109352K961413SYNTHES ANATOMICAL LOCKING PLATE SYSTEMHWC1996-08-07
238981564258700K961350SYNTHES MINI EXTERNAL FIXATORKTT1996-06-28
1301051802476076K953644VOLAR DISTAL RADIUS PLATEHRS1996-03-08
1300991228961395K952296SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREWHWC1995-08-18
239011064273807K950384SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATORLXT1995-05-22
1301051915578847K914546ANGLED BLADE PLATEKTW1991-11-29
1301051019199987K904553BONE STAPLE(S)JDR1990-12-21
1300991181464893K792291SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATESKTW1979-12-06
1301051181464893K792291SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATESKTW1979-12-06
1301051624770774K791619DYNAMIC HIP SCREWKTT1979-08-28
1301051600907927K190409MatrixRIB Fixation SystemHRS2019-05-03
239011600907927K190409MatrixRIB Fixation SystemHRS2019-05-03
1301051114901093K182154Depuy Synthes Femoral Neck SystemKTT2018-10-16
239011178216290K181231DePuy Synthes T-PAL Spacer SystemMAX2018-12-06
239011403669492K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsHWC2018-11-21
1301051403669492K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsHWC2018-11-21
1301051000822572K172872DePuy Synthes Femoral Neck SystemKTT2018-03-05
238981330732265K172157DePuy Synthes Femoral Recon Nail SystemHSB2017-11-14
239011330732265K172157DePuy Synthes Femoral Recon Nail SystemHSB2017-11-14
1301051330732265K172157DePuy Synthes Femoral Recon Nail SystemHSB2017-11-14
1301052027876276K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression ScrewHWC2017-02-16
1300991248512751K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT2016-11-10
238981134768708K160167DePuy Synthes TFNA Augmentation SystemHSB2016-09-26
239011289933611K152239Zero-P Natural Plate SystemKWQ2015-12-02
239011690892650K151276DePuy Synthes T-PAL Ti SpacerMAX2015-06-18
238981780137436K150796Dental Bone Cutting InstrumentsDZJ2015-06-23
239012065908833K150673SYNFIX Evolution Secured Spacer SystemOVD2015-08-21
1301051721789286K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)HRS2015-03-23
238981070231278K141796DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEMHRS2014-08-29
1301051070231278K141796DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEMHRS2014-08-29
1300991070231278K141796DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEMHRS2014-08-29
1301051786262007K141527DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEMHRS2015-03-30
238981713062421K131548SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEMHSB2014-02-28
239011713062421K131548SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEMHSB2014-02-28
1301051862547101K131186SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEMHRS2013-10-08
239011717030337K122639SYNTHES SYNCAGE EVOLUTION SPACERMAX2013-05-24
1300991063386380K122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMKTT2013-04-11
239011842881142K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSHAW2012-12-17
239011510543853K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEHRS2012-07-06
1301051510543853K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEHRS2012-07-06
1300991817057744K120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMHRS2012-06-18
1301051817057744K120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMHRS2012-06-18
239011817057744K120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMHRS2012-06-18
238981333932864K120807SYNTHES MULTILOC HUMERAL NAILING SYSTEMHSB2012-07-06
239011333932864K120807SYNTHES MULTILOC HUMERAL NAILING SYSTEMHSB2012-07-06
1300991011390916K120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)HRS2012-05-08
1300991179778020K120689SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEMHRS2012-06-04
1301051179778020K120689SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEMHRS2012-06-04
239011179778020K120689SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEMHRS2012-06-04
1301051901188318K120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)HSB2012-02-08
1300991253877565K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMHRS2012-03-21
1300991498247697K1133642.7MM LCP ULNA OSTEOTOMY SYSTEMHRS2012-02-29
238981498247697K1133642.7MM LCP ULNA OSTEOTOMY SYSTEMHRS2012-02-29
1301051016867459K112583SYNTHES CORTICAL SCREWSHWC2011-12-05
239011009871837K112459SYNTHES ZERO-POVE2011-12-12
1300991597938847K112085SYNTHES LCP PEDIATRIC PLATE SYSTEMSHRS2011-11-17
239011297179419K112068SYNTHES ZERO-P VARIABLE ANGLE (VA)OVE2011-11-07
239012046806480K110789SYNTHES STERNAL ZIPFIX SYSTEMJDQ2011-07-28
239011506096202K1103544.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEMJDP2011-03-04
239011659340349K1101252.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEMHRS2011-04-21
239011887713437K103320SYNTHES XRLMQP2011-10-20
238981186915012K1032432.4MM VA-LCP INTERCARPAL FUSION SYSTEMHRS2011-01-21
1300991186915012K1032432.4MM VA-LCP INTERCARPAL FUSION SYSTEMHRS2011-01-21
1301051186915012K1032432.4MM VA-LCP INTERCARPAL FUSION SYSTEMHRS2011-01-21
239011830419044K103002SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEMHSB2011-03-02
1301051830419044K103002SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEMHSB2011-03-02
1300991617160921K1026942.4MM VA-LCP DORSAL DISTAL RADIUS PLATESHRS2010-12-09
1301051617160921K1026942.4MM VA-LCP DORSAL DISTAL RADIUS PLATESHRS2010-12-09
1300991099334354K100776SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEMHRS2010-08-03
1301051099334354K100776SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEMHRS2010-08-03
1300991137183733K100676SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALLHRS2010-04-08
239011327887609K100089SYNTHES T-PAL SPACERMAX2010-05-13
239011320874072K093762SYNTHES ZERO-POVE2010-12-20
239011406669477K092646SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREWHSB2009-09-25
1301051728219681K092609SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)HRS2009-11-17
1301051221481191K091644SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATESHRS2009-12-23
1301051615281281K090949SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWSHWC2009-07-31
1300992017308462K090658SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONALKTT2010-03-03
238982017308462K090658SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONALKTT2010-03-03
1301052016906453K090241SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)HSB2009-06-17
1301051625156367K090047SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEMHRS2009-04-01
1300991000144129K083694SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATESHRS2009-03-06
1300991645155442K083573SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATESHRS2009-03-04
1301051645155442K083573SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATESHRS2009-03-04
1301051534943442K082807SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONSHRS2008-11-24
1300991943536948K082650SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONALKTT2008-11-18
239011384313784K082649SYNTHES 90 DEGREE SCREWDRIVERDZI2009-04-30
239011161039568K082572USS ILIOSACRAL, USS POLYAXIALNKB2008-11-24
1300991161039568K082572USS ILIOSACRAL, USS POLYAXIALNKB2008-11-24
1301051960075378K082148SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSIONHSB2008-08-11
1301051264467004K081452SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEMHSB2008-07-18
1301051800275360K080943SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWSHWC2008-04-23
1300991688933422K080331SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEMJEY2008-04-30
239011762205938K072981SYNTHES ZERO-POVE2008-02-11
238981586095565K072253SYNFIX-LR SPACEROVD2007-10-12
1301051586095565K072253SYNFIX-LR SPACEROVD2007-10-12
1300991174103698K072095SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONSJDS2007-09-27
238981822129986K071476SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMPJEC2007-08-24
1301051882542968K071264SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULEHRS2007-07-09
239011084175543K070843SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEMHSB2007-05-02
238982029254203K063832SYNTHES (USA) ELBOW HINGE FIXATORLXT2007-03-07
1301051970390470K063049SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEMHRS2006-12-18
1300991038295451K062872SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEMJDS2007-03-13
1301051556510506K062564SYNTHES LCP DISTAL FEMUR PLATESHRS2006-10-19
1300991873038043K061753SYNTHES (USA) CLAVICLE HOOK PLATESHRS2006-08-04
1301051116311866K053508SYNFIX-LRMQP2006-02-13
1301051926263933K053105SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAPHSB2005-12-02
1301051522414117K052677SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)HRS2005-10-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS582019-05-03
KTT202018-10-16
HSB202017-11-14
HWC152018-11-21
LXT62007-03-07
KWQ52015-12-02
KTW52001-09-06
MAX42018-12-06
OVE42011-12-12
JDS42007-09-27
MNI42003-03-24
OVD32015-08-21
JEY32008-04-30
MQN32005-03-15
MQP22011-10-20
NKB22008-11-24
DZJ12015-06-23
HAW12012-12-17
JDQ12011-07-28
JDP12011-03-04
DZI12009-04-30
JEC12007-08-24
HWE12005-01-05
KWP12003-11-14
HTN12002-01-30
JDW12000-11-20
FQP11999-12-06
MNH11996-12-09
JDR11990-12-21