FDA.reportPublic FDA data

SYNTHES

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
30088125603008812560Synthes (USA) Products LLC1Y2026-01-011301 Goshen Pkwy West Chester PA US 19380
17190451719045SYNTHES (USA), LLC1Y2020-04-251051 Synthes Ave MONUMENT CO US 80132
25300881000221230SYNTHES (USA) PRODUCTS LLC1N2020-04-251303 Goshen Pkwy West Chester PA US 19380
29392742939274Synthes (USA) Products LLC1N2020-04-251230 Wilson Dr West Chester PA US 19380
96124883002807651Synthes Produktions GmbH1N2020-04-25MURACHERSTRASSE 3 BETTLACH Solothurn CH 2544
96809383004186932SYNTHES TUTTLINGEN1N2020-04-25UNTER HASSLEN 5 TUTTLINGEN Baden-Wurttemberg DE 78532
10005629541000562954SYNTHES PRODUCTION GMBH1N2020-04-25Via Cavazz 5 Ticino, CH-6805 MEZZOVICO Ticino CH CH-6805
30035068833003506883SYNTHES (USA) LLC1N2020-04-2535 AIRPORT RD. HORSEHEADS NY US 14845
30038622133003862213Synthes GmbH (DE)1N2020-04-25IM KIRCHENHURSTLE 4 UMKIRCH B. FREIBURG Baden-Wurttemberg DE D-79224
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
30099968083009996808SYNTHES USA PRODUCTS, LLC1N2020-04-25325 Paramount Drive Raynham MA US 02767
30101973483010197348Synthes USA1N2020-04-251210 Ward Ave West Chester PA US 19380

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
10705034763743ProDisc-C - PRODISC-C IMPLANT MEDIUM 7MM-STERILE+1(800)255-2500xx@xx.xx
10705034763774ProDisc-C - PRODISC-C IMPLANT MEDIUM DEEP 7MM-STERILE+1(800)255-2500xx@xx.xx
10886982229397NA - TI END CAP 15MM EXT FOR TI SOLID TIBIAL NAILS+1(800)255-2500xx@xx.xx
10886982232090NA - TI END CAP 5MM EXT FOR HUMERAL NAIL SPIRAL BLADE+1(800)255-2500xx@xx.xx
10886982232113NA - TI END CAP 10MM EXT FOR HUMERAL NAIL SPIRAL BLADE+1(800)255-2500xx@xx.xx
10886982232137NA - TI END CAP 15MM EXT FOR HUMERAL NAIL SPIRAL BLADE+1(800)255-2500xx@xx.xx
10886982255297NA - LID FOR 255MM X 250MM GRAPHIC CASES+1(800)255-2500xx@xx.xx
20705034771950NA - PIPE ROD BENDERS+1(800)255-2500xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1636751441420745P070001PRODISC TM-C TOTAL DISC REPLACEMENTMJO2007-12-17
1581901963608825P070001PRODISC TM-C TOTAL DISC REPLACEMENTMJO2007-12-17
77371963608825P070001PRODISC TM-C TOTAL DISC REPLACEMENTMJO2007-12-17
77381963608825P070001PRODISC TM-C TOTAL DISC REPLACEMENTMJO2007-12-17
1242451963608825P070001PRODISC TM-C TOTAL DISC REPLACEMENTMJO2007-12-17
77381799236197P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1242451799236197P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1581901799236197P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1636752034302737P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1581902040373875P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
77372040373875P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
77382040373875P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1242452040373875P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
239001091750361K994364SYNTHES BUTTON PLATEMBI2000-03-15
77371979326789K994364SYNTHES BUTTON PLATEMBI2000-03-15
1242451979326789K994364SYNTHES BUTTON PLATEMBI2000-03-15
1581901979326789K994364SYNTHES BUTTON PLATEMBI2000-03-15
239001179110603K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
1636751242400662K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
1581901767473167K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
77371767473167K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
77381767473167K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
1242451677234597K994161SYNTHES BIORESORBABLE SUTURE ANCHORMAI2000-07-28
1581901677234597K994161SYNTHES BIORESORBABLE SUTURE ANCHORMAI2000-07-28
1581901185275357K994121SMALL STATURE USSMNI2000-10-17
77371185275357K994121SMALL STATURE USSMNI2000-10-17
77381185275357K994121SMALL STATURE USSMNI2000-10-17
77391185275357K994121SMALL STATURE USSMNI2000-10-17
1242451185275357K994121SMALL STATURE USSMNI2000-10-17
1636751292995323K994121SMALL STATURE USSMNI2000-10-17
239001675561040K994121SMALL STATURE USSMNI2000-10-17
1242451358240838K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMHTO2000-06-12
1581901358240838K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMHTO2000-06-12
239011100181742K993314SYNTHES LIGHT GUIDEFQP1999-12-06
77371313223531K993314SYNTHES LIGHT GUIDEFQP1999-12-06
1242451313223531K993314SYNTHES LIGHT GUIDEFQP1999-12-06
1581901313223531K993314SYNTHES LIGHT GUIDEFQP1999-12-06
1636751612491835K993314SYNTHES LIGHT GUIDEFQP1999-12-06
1581901510491167K992891SYNTHES CERCLAGE POSITIONING PINJDQ1999-11-02
77371510491167K992891SYNTHES CERCLAGE POSITIONING PINJDQ1999-11-02
1242451510491167K992891SYNTHES CERCLAGE POSITIONING PINJDQ1999-11-02
1242451320717995K9928373.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)KTW1999-10-25
1581901320717995K9928373.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)KTW1999-10-25
1581901056417625K992739CLICK'XMNH2000-02-08
77371056417625K992739CLICK'XMNH2000-02-08
77381056417625K992739CLICK'XMNH2000-02-08
77391056417625K992739CLICK'XMNH2000-02-08
1636751907678622K992739CLICK'XMNH2000-02-08
239002068722905K992739CLICK'XMNH2000-02-08
77371270524458K992617HEX BUTTONHTN1999-10-27
1242451270524458K992617HEX BUTTONHTN1999-10-27
1581901270524458K992617HEX BUTTONHTN1999-10-27
1581901382361674K992616SDB CERCLAGE SYSTEMJDQ1999-10-27
77371382361674K992616SDB CERCLAGE SYSTEMJDQ1999-10-27
1242451382361674K992616SDB CERCLAGE SYSTEMJDQ1999-10-27
77371184357412K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
77381184357412K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
77391184357412K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
1242451184357412K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
1581901184357412K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
239001388207961K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
77371879920802K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
1242451879920802K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
1581901879920802K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
1581901251875950K991860SYNTHES CRANIAL FLAP TWIST CLAMPGXN1999-07-20
1242451251875950K991860SYNTHES CRANIAL FLAP TWIST CLAMPGXN1999-07-20
1636751526952551K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
1581901786620850K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
77371786620850K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
77381786620850K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
1242451786620850K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
77371498205691K991407SYNTHES LOCKING CALCANEAL PLATESLXT1999-06-11
77391498205691K991407SYNTHES LOCKING CALCANEAL PLATESLXT1999-06-11
1242451498205691K991407SYNTHES LOCKING CALCANEAL PLATESLXT1999-06-11
1581901498205691K991407SYNTHES LOCKING CALCANEAL PLATESLXT1999-06-11
1581901353100319K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
77371353100319K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
77381353100319K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
1242451353100319K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
1636751715412671K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
1581901347616384K991004SYNTHES QUICK LOCK IMF SYSTEMDYX1999-06-23
1242451347616384K991004SYNTHES QUICK LOCK IMF SYSTEMDYX1999-06-23
239001186478782K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
1636751253310120K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
1581901783983571K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
77371783983571K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
77381783983571K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
1242451783983571K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
1636751004683311K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
239001055507609K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
77371588402404K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
77381588402404K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
77391588402404K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
1242451588402404K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
1581901588402404K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
239001391542326K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
77371468193880K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
1242451468193880K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
1581901468193880K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
239001209133005K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
1636751295348043K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
1581901439673375K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
77371439673375K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
77381439673375K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
77391439673375K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
1242451439673375K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
77371450745994K984498SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEMKTT1999-02-18
1242451450745994K984498SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEMKTT1999-02-18
1581901450745994K984498SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEMKTT1999-02-18
1581901090452243K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
77371090452243K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
77381090452243K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
1242451090452243K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
1636751978190890K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
1581902072621255K983787SYNTHES PROXIMAL TIBIA PLATING SYSTEMHRS1999-01-21
77372072621255K983787SYNTHES PROXIMAL TIBIA PLATING SYSTEMHRS1999-01-21
1242452072621255K983787SYNTHES PROXIMAL TIBIA PLATING SYSTEMHRS1999-01-21
77371595461307K983766SYNTHES SYNMESHEZX1998-12-18
77381595461307K983766SYNTHES SYNMESHEZX1998-12-18
77391595461307K983766SYNTHES SYNMESHEZX1998-12-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS4882026-03-09
JEY1702020-09-10
KTT1602023-07-26
KWQ1472015-12-02
HWC1372019-11-26
HSB1242024-08-01
KWP1222014-10-01
NKB822017-03-29
MNI772012-02-01
MQP542019-05-23
LXT542008-01-29
MQN522019-03-13
MNH482006-07-12
DZL422010-01-25
JDS392020-09-03
JDQ392018-06-21
OVE362012-07-25
MQV332011-01-27
KTW312008-03-20
MAX292018-12-06
JDR252020-02-26
HTN192020-04-06
HTY182014-01-09
GXP172010-09-23
JDW172004-04-12
GXR162013-08-16
GXN152025-11-12
OVD152015-08-21
NDN142013-05-20
HWE142005-01-05
JDO141998-07-17
MJO132007-12-17
GWO122014-06-13
NEI122008-09-05
HTO112011-08-10
JEC102007-08-24
GXQ92022-01-28
JDP82017-03-29
MBI82016-05-05
LYC82006-01-23

PMA#

PMN#

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next