FDA.reportPublic FDA data

SYNTHES USA PRODUCTS, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30099968083009996808SYNTHES USA PRODUCTS, LLC1N2020-04-25325 Paramount Drive Raynham MA US 02767

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1636751441420745P070001PRODISC TM-C TOTAL DISC REPLACEMENTMJO2007-12-17
1636752034302737P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1636751242400662K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
1636751292995323K994121SMALL STATURE USSMNI2000-10-17
1636751612491835K993314SYNTHES LIGHT GUIDEFQP1999-12-06
1636751907678622K992739CLICK'XMNH2000-02-08
1636751526952551K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
1636751715412671K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
1636751253310120K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
1636751004683311K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
1636751295348043K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
1636751978190890K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
1636751853041958K983766SYNTHES SYNMESHEZX1998-12-18
1636751263141144K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
1636751625361453K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
1636751242958573K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
1636751123814477K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
1636751277829076K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
1636751040114027K980358SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEMKWP1998-04-16
1636751756354778K974525SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEMKWQ1998-03-02
1636751906685975K971883SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMKWQ1997-10-16
1636751953393713K970048SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)KWQ1997-08-01
1636751818545303K964416SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEMKWQ1997-03-17
1636751282780061K963357MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STEMNH1997-01-09
1636752008822700K963045SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEMMNH1997-02-13
1636751741324864K962608SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTORMNH1996-12-09
1636751507083417K951626SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEMMNH1995-08-21
1636752009118621K945700SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMKWQ1995-07-20
1636751781954546K943725UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEMKWQ1995-08-25
1636751547638368K930891SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYSTKWP1994-04-29
1636752029758542K926453SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATEKWQ1993-10-12
1636751405996680K925351SYNTHES(U.S.A.) ANTERIOR SPINAL PLATEKWQ1993-11-05
1636751463747492K922855SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYSKWQ1993-06-24
1636751957621223K921948SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYSTKWP1993-06-22
1636751774649755K792352SYNTHES CERVICAL VERTABRAE PLATESKWQ1979-12-06
1636751164298481K181231DePuy Synthes T-PAL Spacer SystemMAX2018-12-06
1636751732481848K170654USS SystemNKB2017-03-29
1636751980383289K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemMAX2016-11-01
1636751579836642K152239Zero-P Natural Plate SystemKWQ2015-12-02
1636751021199653K151276DePuy Synthes T-PAL Ti SpacerMAX2015-06-18
1636751304389472K150673SYNFIX Evolution Secured Spacer SystemOVD2015-08-21
1636751761831419K142838Synapse Occipital-Cervical-Thoracic (OCT) SystemNKG2015-01-20
1636751484930330K142587Vertical Expandable Prosthetic Titanium RibMDI2014-11-18
1636752037663791K141897SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMKWP2014-09-25
1636751484021936K133698SYNAPSE SYSTEMKWP2014-01-16
1636751046016196K132910DEPUY SYNTHES SPINE DENS ACCESS SYSTEMHWC2013-12-16
1636751994264242K131276LATERAL SYNFIXOVD2014-01-06
1636751678771994K130146SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEMNDN2013-05-20
1636751808299607K123180FALCON SPACERMAX2013-01-08
1636751390896338K122639SYNTHES SYNCAGE EVOLUTION SPACERMAX2013-05-24
1636751099780095K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSHAW2012-12-17
1636751961050113K121852SYNTHES ZERO-P VARIABLE ANGLE (VA)OVE2012-07-25
1636751394764392K120928SYNTHES MATRIX SYSTEMNKB2012-05-18
1636751518643615K120838SYNTHES MATRIX SYSTEMNKB2012-07-31
1636751791945291K120571SYNTHES USS CONNECTORNKB2012-05-14
1636751863624507K120275SYNTHES ACIS/VERTEBRAL SPACER CRODP2012-05-25
1636751544002489K113149SYNTHES USS CONNECTORSMNI2012-02-01
1636751865022993K113044SYNTHES MIRSNKB2011-12-21
1636751086305867K112459SYNTHES ZERO-POVE2011-12-12
1636751313107877K112068SYNTHES ZERO-P VARIABLE ANGLE (VA)OVE2011-11-07
1636751470590784K111358SYNTHES USSNKB2011-11-18
1636751248376748K111048SYNTHES SCOUT TACK FIXATIONOMR2012-06-14
1636751956142424K110604VBB SYSTEMNDN2011-12-13
1636751601539979K103558SYNTHES SCOUT VESSEL GUARDOMR2011-02-18
1636751153946466K103320SYNTHES XRLMQP2011-10-20
1636751827314696K103287SYNTHES 6.0 COCR AND CPT TI-3 RODSNKB2011-01-05
1636751524247910K100952MODIFICATION TO SYNTHES MATRIX SYSTEMNKB2010-08-05
1636751211251815K100634SYNTHES MATRIX SYSTEMNKB2010-07-01
1636752017835544K100089SYNTHES T-PAL SPACERMAX2010-05-13
1636751745009594K093762SYNTHES ZERO-POVE2010-12-20
1636751533126805K093668SYNTHES MATRIX MIS RODSNKB2010-03-09
1636751425256594K092929SYNTHES MATRIX SYSTEMNKB2009-12-29
1636751100154753K091689SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MMKWP2009-07-10
1636751072987668K091159SYNTHES ORACLE PLATEKWQ2009-07-10
1636751806650942K090605CLAMPFIXNKB2009-11-06
1636751346805717K090549SYNTHES SYNAPSE TRANSCONNECTORKWP2009-05-21
1636751367707040K090435VERTECEMNDN2009-12-21
1636751401325902K082914CLAMPFIXNKB2008-12-11
1636751405450927K082572USS ILIOSACRAL, USS POLYAXIALNKB2008-11-24
1636751202360792K081568ANTEGRA-TKWQ2008-09-02
1636751348823098K080020ARCOFIXKWQ2008-05-23
1636751660554052K072981SYNTHES ZERO-POVE2008-02-11
1636752033880743K072791ORACLE SPACER, OPAL SPACERMAX2007-12-26
1636751436874853K072434SYNTHES OC FUSION AND SYNAPSE SYSTEMSMNI2008-01-10
1636751933722020K072253SYNFIX-LR SPACEROVD2007-10-12
1636751816537443K071667SYNTHES VECTRA-ONE SYSTEMKWQ2007-11-30
1636751438103174K070573SYNAPSE SYSTEMMNI2007-06-08
1636751915036939K063158SYNTHES ANTEGRA SYSTEMKWQ2006-11-14
1636751560381590K062933SYNTHES ORACLE SPACERMQP2007-01-31
1636751543120290K062083SYNFIX -LRMQP2007-04-03
1636751876730666K061891SYNEX IIMQP2006-08-18
1636751516147511K053508SYNFIX-LRMQP2006-02-13
1636751562176585K053418SYNTHES OC FUSION SYSTEMKWP2006-09-06
1636751849959166K052151SYNTHES PANGEA MONOAXIAL SYSTEMNKB2005-12-07
1636751541553994K052123SYNTHES PANGEA SYSTEMKWP2005-09-23
1636751232886814K051665SYNTHES VECTRA-T SYSTEMKWQ2005-09-09
1636751016179231K050451SYNTHES VECTRA SYSTEMKWQ2005-03-24
1636751308271034K041389SYNTHES CONTOURED SYNMESH SPACERMQP2004-10-01
1636751908081562K033844SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEMKWQ2004-02-05
1636751991463951K032534SYNTHES AFSNQW2004-04-01
1636751952661574K031276SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEMKWQ2003-07-02
1636751905029719K031175CLICK'X MONOAXIAL SCREWS AND HOOKSKWP2003-11-14
1636751988743744K031100SYNTHES VENTROFIX MIS SYSTEMKWQ2004-03-04
1636751486210325K030866SYNTHES ANTERIOR CSLP SYSTEMKWQ2003-04-18
1636751731070818K030377MODIFICATION TO SYNTHES CERVIFIX SYSTEMMNI2003-03-06
1636751709440067K024364SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)MQP2003-03-17
1636751448074900K023675SYNTHES CERVIFIX/ AXONKWP2002-11-26
1636751171013066K022949SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USSMNI2003-03-24
1636751314974556K022791SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEMKWQ2002-11-13
1636751807006451K020517SYNTHES DUAL-OPENING USSMNI2002-04-15
1636751841018445K020244SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)KWQ2002-04-22
1636751218579936K020152SYNTHES VERTEBRAL SPACER TIMQP2002-04-16
1636752063436974K011969SYNTHES CERVIFIX SYSTEMKWP2001-07-19
1636751232872065K011037VERTEBRAL SPACERMQP2002-07-01
1636751627864123K010658MODIFIED USS FRACTURE SYSTEMMNI2001-06-04
1636751356960391K010108USS-LINE EXTENSIONMNI2001-06-06
1636751533478612K003836SYNTHES SYNEX SPACER SYSTEMMQP2001-05-29
1636751299759078K003275SYNTHES SYNMESH SPACER SYSTEMMQP2001-04-23
1636751271442215K003061SYNTHES USS (10.0MM SIDE OPENING SCREWS)KWQ2000-10-30
1636751602882928K002517USS VASKWP2000-09-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWQ282015-12-02
KWP202014-09-25
NKB152017-03-29
MNI132012-02-01
MQP112011-10-20
MAX72018-12-06
MNH72000-02-08
OVE52012-07-25
OVD32015-08-21
NDN32013-05-20
OMR22012-06-14
MJO22007-12-17
NKG12015-01-20
MDI12014-11-18
HWC12013-12-16
HAW12012-12-17
ODP12012-05-25
NQW12004-04-01
JDW12000-08-24
FQP11999-12-06
EZX11998-12-18

PMN#