FDA.reportPublic FDA data

SYNTHES PRODUCTION GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10005629541000562954SYNTHES PRODUCTION GMBH1N2020-04-25Via Cavazz 5 Ticino, CH-6805 MEZZOVICO Ticino CH CH-6805

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
239001091750361K994364SYNTHES BUTTON PLATEMBI2000-03-15
239001179110603K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
239001675561040K994121SMALL STATURE USSMNI2000-10-17
239002068722905K992739CLICK'XMNH2000-02-08
239001388207961K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
239001186478782K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
239001055507609K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
239001391542326K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
239001209133005K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
239001195584599K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
239001791837902K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
239001532872978K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
239001816942914K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
239001822953415K971883SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMKWQ1997-10-16
239002047627247K970048SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)KWQ1997-08-01
239001798078228K964416SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEMKWQ1997-03-17
239001742648757K963357MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STEMNH1997-01-09
239001823851961K963045SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEMMNH1997-02-13
239001115203201K962616SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEMHRS1996-09-03
239001254603165K962608SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTORMNH1996-12-09
239001353440751K962047TITANIUM CANNULATED TIBIAL NAIL (TI CTN)JDS1996-07-24
239001225109352K961413SYNTHES ANATOMICAL LOCKING PLATE SYSTEMHWC1996-08-07
239001787448903K951626SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEMMNH1995-08-21
239001692478342K945700SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMKWQ1995-07-20
239001061133009K943725UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEMKWQ1995-08-25
239001064846221K930891SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYSTKWP1994-04-29
239001880368507K926453SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATEKWQ1993-10-12
239001330732265K172157DePuy Synthes Femoral Recon Nail SystemHSB2017-11-14
239001426607690K163046DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-LongHRS2017-02-09
239001936231404K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning PinsJDP2017-03-29
239001758830261K161590MatrixRIB Fixation SystemHRS2016-11-03
239001289933611K152239Zero-P Natural Plate SystemKWQ2015-12-02
239001690892650K151276DePuy Synthes T-PAL Ti SpacerMAX2015-06-18
239002065908833K150673SYNFIX Evolution Secured Spacer SystemOVD2015-08-21
239001981951106K142838Synapse Occipital-Cervical-Thoracic (OCT) SystemNKG2015-01-20
239001266135322K141897SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMKWP2014-09-25
239001786262007K141527DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEMHRS2015-03-30
239001566086020K133698SYNAPSE SYSTEMKWP2014-01-16
239001629254892K133616MATRIXRIB FIXATION SYSTEMHRS2014-05-02
239001585472462K131276LATERAL SYNFIXOVD2014-01-06
239001063386380K122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMKTT2013-04-11
239001780133005K121852SYNTHES ZERO-P VARIABLE ANGLE (VA)OVE2012-07-25
239001479594936K120928SYNTHES MATRIX SYSTEMNKB2012-05-18
239001817057744K120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMHRS2012-06-18
239001333932864K120807SYNTHES MULTILOC HUMERAL NAILING SYSTEMHSB2012-07-06
239001011390916K120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)HRS2012-05-08
239001179778020K120689SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEMHRS2012-06-04
239001253877565K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMHRS2012-03-21
239001498247697K1133642.7MM LCP ULNA OSTEOTOMY SYSTEMHRS2012-02-29
239001246367679K113251SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATESJEY2011-12-21
239001830468260K113149SYNTHES USS CONNECTORSMNI2012-02-01
239001385138104K113044SYNTHES MIRSNKB2011-12-21
239001016867459K112583SYNTHES CORTICAL SCREWSHWC2011-12-05
239001009871837K112459SYNTHES ZERO-POVE2011-12-12
239001297179419K112068SYNTHES ZERO-P VARIABLE ANGLE (VA)OVE2011-11-07
239001472077714K111540SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEMHRS2011-08-08
239001506096202K1103544.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEMJDP2011-03-04
239001659340349K1101252.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEMHRS2011-04-21
239001593046424K103287SYNTHES 6.0 COCR AND CPT TI-3 RODSNKB2011-01-05
239001186915012K1032432.4MM VA-LCP INTERCARPAL FUSION SYSTEMHRS2011-01-21
239001830419044K103002SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEMHSB2011-03-02
239001617160921K1026942.4MM VA-LCP DORSAL DISTAL RADIUS PLATESHRS2010-12-09
239001980283254K100952MODIFICATION TO SYNTHES MATRIX SYSTEMNKB2010-08-05
239002047121140K100634SYNTHES MATRIX SYSTEMNKB2010-07-01
239001464874389K093772SYNTHES STERNAL FIXATION SYSTEMHRS2010-03-29
239001320874072K093762SYNTHES ZERO-POVE2010-12-20
239001217187791K093668SYNTHES MATRIX MIS RODSNKB2010-03-09
239001544385194K092929SYNTHES MATRIX SYSTEMNKB2009-12-29
239001688866439K092556SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUSHRS2009-11-17
239001388701421K092247SYNTHES LOCKING HAND PLATESHRS2009-09-25
239001325180531K091689SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MMKWP2009-07-10
239001221481191K091644SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATESHRS2009-12-23
239001917708904K091144SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATESJEY2009-08-25
239001105057185K090605CLAMPFIXNKB2009-11-06
239002036064657K090549SYNTHES SYNAPSE TRANSCONNECTORKWP2009-05-21
239001000144129K083694SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATESHRS2009-03-06
239001640597699K083388SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEMJEY2009-03-12
239001407065393K083025SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEMHRS2009-01-14
239001804518225K082914CLAMPFIXNKB2008-12-11
239001943536948K082650SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONALKTT2008-11-18
239001579557172K082624SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATESHRS2008-11-10
239001161039568K082572USS ILIOSACRAL, USS POLYAXIALNKB2008-11-24
239001493199036K082072SYNTHES (USA) 3.5MM LCP HOOK PLATEHRS2008-11-07
239001869209654K081747MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEMNEI2008-09-05
239001793847398K081700SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSIONHWC2008-07-17
239001631241591K081623SYNTHES RIB FIXATION SYSTEMHRS2008-09-08
239001762205938K072981SYNTHES ZERO-POVE2008-02-11
239001624504707K071667SYNTHES VECTRA-ONE SYSTEMKWQ2007-11-30
239001882542968K071264SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULEHRS2007-07-09
239001415724733K070573SYNAPSE SYSTEMMNI2007-06-08
239001830986075K063181SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEMNEI2007-01-05
239001970390470K063049SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEMHRS2006-12-18
239001556510506K062564SYNTHES LCP DISTAL FEMUR PLATESHRS2006-10-19
239001617165733K053418SYNTHES OC FUSION SYSTEMKWP2006-09-06
239001866738386K052151SYNTHES PANGEA MONOAXIAL SYSTEMNKB2005-12-07
239001104110562K052123SYNTHES PANGEA SYSTEMKWP2005-09-23
239001369073174K051678SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEMHSB2005-09-21
239001516156457K051665SYNTHES VECTRA-T SYSTEMKWQ2005-09-09
239001326083717K050683SYNTHES (USA) 3.5MM CONICAL SCREWSHWC2005-04-27
239001756788951K050451SYNTHES VECTRA SYSTEMKWQ2005-03-24
239002028707296K050110SYNTHES (USA) LCP MODULAR FOOT PLATESHRS2005-03-04
239001883002240K043555SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTORMQN2005-04-12
239001313473086K041860SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONGHRS2004-09-08
239001653917606K040336SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEMHSB2004-04-12
239001510928033K0339953.5 MM LCP DISTAL HUMERUS SYSTEMKTT2004-03-01
239001083547905K032534SYNTHES AFSNQW2004-04-01
239001895164481K031276SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEMKWQ2003-07-02
239001289498285K031175CLICK'X MONOAXIAL SCREWS AND HOOKSKWP2003-11-14
239001907916385K030866SYNTHES ANTERIOR CSLP SYSTEMKWQ2003-04-18
239001643000192K030377MODIFICATION TO SYNTHES CERVIFIX SYSTEMMNI2003-03-06
239001087138037K030310SYNTHES STAINLESS STEEL MODULAR HAND SYSTEMHRS2003-04-22
239002051725534K023941SYNTHES TOMOFIX OSTEOTOMY SYSTEMKTT2003-01-23
239001023396175K023675SYNTHES CERVIFIX/ AXONKWP2002-11-26
239001793233980K022949SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USSMNI2003-03-24
239002035798145K020602SYNTHES PILON PLATEHRS2002-05-20
239001318230420K020517SYNTHES DUAL-OPENING USSMNI2002-04-15
239001388406262K012114SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEMHRS2001-09-28
239001140640744K010766SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATEKTT2001-06-12
239001474720891K010321MODULAR FOOT SYSTEM - 2.7 MM MODULEKTW2001-05-02
239002054232937K010108USS-LINE EXTENSIONMNI2001-06-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS322017-02-09
KWQ162015-12-02
KWP142014-09-25
NKB112012-05-18
MNI112012-02-01
KTT72013-04-11
MNH62000-02-08
HSB52017-11-14
OVE52012-07-25
HWC42011-12-05
JEY32011-12-21
NEI32008-09-05
JDP22017-03-29
OVD22015-08-21
MAX12015-06-18
NKG12015-01-20
MQN12005-04-12
NQW12004-04-01
MQP12001-05-29
KTW12001-05-02
MBI12000-03-15
GXN11999-07-20
JDS11996-07-24