FDA.reportPublic FDA data

SYNTHES (USA), LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
17190451719045SYNTHES (USA), LLC1Y2020-04-251051 Synthes Ave MONUMENT CO US 80132

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
77371963608825P070001PRODISC TM-C TOTAL DISC REPLACEMENTMJO2007-12-17
77372040373875P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
77371979326789K994364SYNTHES BUTTON PLATEMBI2000-03-15
77371767473167K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
77371185275357K994121SMALL STATURE USSMNI2000-10-17
77371313223531K993314SYNTHES LIGHT GUIDEFQP1999-12-06
77371510491167K992891SYNTHES CERCLAGE POSITIONING PINJDQ1999-11-02
77371056417625K992739CLICK'XMNH2000-02-08
77371270524458K992617HEX BUTTONHTN1999-10-27
77371382361674K992616SDB CERCLAGE SYSTEMJDQ1999-10-27
77371184357412K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
77371879920802K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
77371786620850K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
77371498205691K991407SYNTHES LOCKING CALCANEAL PLATESLXT1999-06-11
77371353100319K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
77371783983571K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
77371588402404K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
77371468193880K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
77371439673375K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
77371450745994K984498SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEMKTT1999-02-18
77371090452243K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
77372072621255K983787SYNTHES PROXIMAL TIBIA PLATING SYSTEMHRS1999-01-21
77371595461307K983766SYNTHES SYNMESHEZX1998-12-18
77371139268263K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
77371984599299K983485SYNTHES 1.3 MM SELF-DRILLING SCREWDZL1998-12-21
77371833747714K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
77371519944925K982732SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)HRS1998-10-08
77371216956723K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
77371271270583K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMHWC1998-07-29
77371833874342K981890SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATESJEY1998-08-18
77371428712946K981757SYNTHES (USA) DHS HELIX SYSTEMJDO1998-07-17
77371448444230K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
77371324113405K981275SYNTHES (USA) RATCHETING DISTRACTORMQN1998-06-25
77371351009053K980944SYNTHES SCHUHLI IMPLANT SYSTEMHTN1998-04-27
77371533029117K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
77371079679983K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
77371784059792K980358SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEMKWP1998-04-16
77371840575767K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
77371940599450K974908SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATESHRS1998-03-18
77372006021350K974555SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)JEY1998-03-03
77371098644880K974554SYNTHES RESORBABLE FIXATION SYSTEMJEY1998-02-24
77371954031127K974537SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEMKTT1998-02-18
77371403275692K974525SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEMKWQ1998-03-02
77372024461820K973018SYNTHES MINI LENGTHENING APPARATUSMQN1997-11-10
77371163573533K971987SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORJEY1997-06-24
77371277512265K971883SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMKWQ1997-10-16
77371178536798K971783SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEMHTY1997-07-18
77371618380134K971544SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)HWE1997-05-28
77371365910962K970733SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEMHTY1997-04-02
77372034641955K970097PROXIMAL FEMORAL NAIL (PFN) SYSTEMJDW1997-03-13
77371266725808K970048SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)KWQ1997-08-01
77372062506455K964416SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEMKWQ1997-03-17
77371777898131K964328SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATEJEY1996-12-13
77371429862248K964261SMF STAINLESS STEEL BONE SCREWSDZL1997-04-11
77371785754183K964259SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATIONJDO1997-01-09
77371343905655K963618SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)LXT1996-11-12
77371651579765K963546SMF TITANIUM (TI) ALLOY BONE SCREWSDZL1997-06-24
77371107195519K963357MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STEMNH1997-01-09
77371945648344K963325SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEMHRS1997-03-25
77371977116083K963192SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWSHWC1996-11-08
77371177443323K963172SYNTHES STERILE 4.5 MM CANNULATED SCREWSHWC1996-11-08
77371300642532K963045SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEMMNH1997-02-13
77371230152201K962913SYNTHES STERILE DRILL BITSHWE1996-11-14
77371080653465K962894SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEMHRS1996-12-17
77371863984346K962823SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHERHWC1996-10-01
77371410252721K962616SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEMHRS1996-09-03
77371037620460K962608SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTORMNH1996-12-09
77371241181743K962484SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)KTT1996-09-05
77371458841525K962047TITANIUM CANNULATED TIBIAL NAIL (TI CTN)JDS1996-07-24
77371590238976K962011SYNTHES 7.0/7.3 MM CANNULATED SCREWSHWC1996-08-05
77371728353571K961421SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEMJEY1996-06-26
77371944340038K961413SYNTHES ANATOMICAL LOCKING PLATE SYSTEMHWC1996-08-07
77371773315026K961350SYNTHES MINI EXTERNAL FIXATORKTT1996-06-28
77372021747986K954963SCHUHLI IMPLANT SYSTEMHRS1996-03-22
77371854004362K954385SYNTHES MANDIBULAR MODULAR FIXATION SYSTEMJEY1996-03-08
77371440855168K953806SYNTHES (USA) MIDFACIAL SYSTEMJEY1996-03-08
77371053985535K953777SYNTHES WIRE MOUNTJDQ1996-03-08
77371085866931K953644VOLAR DISTAL RADIUS PLATEHRS1996-03-08
77371615228679K952296SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREWHWC1995-08-18
77371498415508K951794SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)MNH1995-08-21
77371923496937K951626SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEMMNH1995-08-21
77371661513399K951304SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHERHWC1995-06-16
77372067940317K950384SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATORLXT1995-05-22
77371347124395K945700SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMKWQ1995-07-20
77371659813468K943725UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEMKWQ1995-08-25
77371344853791K933518SYNTHES UNREAMED HUMERAL NAIL (URHN)HSB1994-03-14
77371939259325K932593ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAILHSB1994-03-10
77371017316721K930891SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYSTKWP1994-04-29
77371298210080K926453SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATEKWQ1993-10-12
77371191821621K925351SYNTHES(U.S.A.) ANTERIOR SPINAL PLATEKWQ1993-11-05
77371704482297K922855SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYSKWQ1993-06-24
77371295169466K921948SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYSTKWP1993-06-22
77371412240282K914558TRAUMAFIX (TM) EXTERNAL FIXATORKTT1992-01-16
77371031351735K914546ANGLED BLADE PLATEKTW1991-11-29
77371645811734K912932SYNTHES MAXILLOFACIAL TITANIUM MICRO SETHRS1991-09-25
77371595546928K792352SYNTHES CERVICAL VERTABRAE PLATESKWQ1979-12-06
77371368713209K792291SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATESKTW1979-12-06
77371821485434K791619DYNAMIC HIP SCREWKTT1979-08-28
77371886088835K191463DePuy Synthes Hammertoe Continuous Compression ImplantJDR2020-02-26
77371704055397K190409MatrixRIB Fixation SystemHRS2019-05-03
77372009070360K183054SYNMESH SystemMQP2019-05-23
77371592371187K181933DePuy Synthes Sterilization Container SystemKCT2019-05-09
77371842214122K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsHWC2018-11-21
77371141403097K172872DePuy Synthes Femoral Neck SystemKTT2018-03-05
77371512967963K172157DePuy Synthes Femoral Recon Nail SystemHSB2017-11-14
77371457264048K170802TRAUMACEM™ V+ Injectable Bone CementLOD2017-09-28
77371372564291K163046DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-LongHRS2017-02-09
77371572953188K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning PinsJDP2017-03-29
77371879494546K161616DePuy 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
77371082645334K161590MatrixRIB Fixation SystemHRS2016-11-03
77371212715777K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT2016-11-10
77371648329377K160167DePuy Synthes TFNA Augmentation SystemHSB2016-09-26
77371829454142K153587Taps for Resorbable ScrewsHBG2017-01-18
77371275357554K152239Zero-P Natural Plate SystemKWQ2015-12-02
77371990558451K151276DePuy Synthes T-PAL Ti SpacerMAX2015-06-18
77371841782790K150796Dental Bone Cutting InstrumentsDZJ2015-06-23
77371563091829K150673SYNFIX Evolution Secured Spacer SystemOVD2015-08-21
77371618610345K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)HRS2015-03-23
77371026679283K142838Synapse Occipital-Cervical-Thoracic (OCT) SystemNKG2015-01-20
77371807689571K142587Vertical Expandable Prosthetic Titanium RibMDI2014-11-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS952019-05-03
JEY362014-10-17
HWC312018-11-21
KTT312018-03-05
KWQ252015-12-02
KWP212014-10-01
HSB202017-11-14
NKB112012-07-31
MNI112012-02-01
DZL112005-04-06
MQN102012-08-23
JDQ102011-07-28
LXT102007-03-07
MQP92019-05-23
MNH82000-02-08
JDS72011-12-05
OVE52012-07-25
KTW52001-09-06
MAX42015-06-18
MQV42011-01-27
JDW42004-04-12
GWO32014-06-13
NDN32013-05-20
HTO32011-08-10
NEI32008-09-05
GXN32005-12-14
HWE32005-01-05
HTN32002-01-30
KCT22019-05-09
JDP22017-03-29
OVD22015-08-21
GXQ22013-12-16
HAW22012-12-17
ETN22011-02-23
GXP22010-09-23
FTM22009-10-22
MJO22007-12-17
GAQ22005-05-27
GXR22004-11-17
JDO21998-07-17

PMN#