FDA.reportPublic FDA data

Synthes (USA) Products LLC

Matched from indexed company URL: SYNTHES (USA) PRODUCTS LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088125603008812560Synthes (USA) Products LLC1Y2027-01-011301 Goshen Pkwy West Chester PA US 19380
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

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
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
77382040373875P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1242452040373875P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1242451979326789K994364SYNTHES BUTTON PLATEMBI2000-03-15
77381767473167K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
1242451677234597K994161SYNTHES BIORESORBABLE SUTURE ANCHORMAI2000-07-28
77381185275357K994121SMALL STATURE USSMNI2000-10-17
1242451185275357K994121SMALL STATURE USSMNI2000-10-17
1242451358240838K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMHTO2000-06-12
1242451313223531K993314SYNTHES LIGHT GUIDEFQP1999-12-06
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
77381056417625K992739CLICK'XMNH2000-02-08
1242451270524458K992617HEX BUTTONHTN1999-10-27
1242451382361674K992616SDB CERCLAGE SYSTEMJDQ1999-10-27
1242451184357412K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
77381184357412K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
1242451879920802K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
1242451251875950K991860SYNTHES CRANIAL FLAP TWIST CLAMPGXN1999-07-20
77381786620850K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
1242451786620850K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
1242451498205691K991407SYNTHES LOCKING CALCANEAL PLATESLXT1999-06-11
77381353100319K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
1242451353100319K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
1242451347616384K991004SYNTHES QUICK LOCK IMF SYSTEMDYX1999-06-23
77381783983571K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
1242451783983571K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
77381588402404K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
1242451588402404K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
1242451468193880K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
77381439673375K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
1242451439673375K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
1242451450745994K984498SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEMKTT1999-02-18
77381090452243K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
1242451090452243K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
1242452072621255K983787SYNTHES PROXIMAL TIBIA PLATING SYSTEMHRS1999-01-21
77381595461307K983766SYNTHES SYNMESHEZX1998-12-18
1242451595461307K983766SYNTHES SYNMESHEZX1998-12-18
77381139268263K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
1242451139268263K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
1242451984599299K983485SYNTHES 1.3 MM SELF-DRILLING SCREWDZL1998-12-21
1471061216387647K983104NORIAN PERIODONTAL/DENTAL CEMENT (PDC)LYC1999-02-12
1242451216387647K983104NORIAN PERIODONTAL/DENTAL CEMENT (PDC)LYC1999-02-12
77381833747714K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
1242451833747714K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
1242451519944925K982732SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)HRS1998-10-08
77381216956723K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
77381271270583K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMHWC1998-07-29
1242451271270583K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMHWC1998-07-29
1242451833874342K981890SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATESJEY1998-08-18
1242451428712946K981757SYNTHES (USA) DHS HELIX SYSTEMJDO1998-07-17
1242451218192818K981372SYNTHES 3.0 MM PC-FIX SYSTEMHWC1998-05-11
1242451448444230K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
1242451324113405K981275SYNTHES (USA) RATCHETING DISTRACTORMQN1998-06-25
1242451065213091K981075SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEETMQN1998-06-22
1242451351009053K980944SYNTHES SCHUHLI IMPLANT SYSTEMHTN1998-04-27
77381533029117K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
77381079679983K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
1242451079679983K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
77381784059792K980358SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEMKWP1998-04-16
1242451784059792K980358SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEMKWP1998-04-16
1242451840575767K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
1242451940599450K974908SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATESHRS1998-03-18
77382006021350K974555SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)JEY1998-03-03
1242452006021350K974555SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)JEY1998-03-03
1471061098644880K974554SYNTHES RESORBABLE FIXATION SYSTEMJEY1998-02-24
1242451954031127K974537SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEMKTT1998-02-18
77381403275692K974525SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEMKWQ1998-03-02
1242451403275692K974525SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEMKWQ1998-03-02
1242451184318858K974206SYNTHES CRANIAL SPRING CLIP (CSC)GWO1998-03-16
1471062016272455K973789NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CCGXP1998-05-18
1242452016272455K973789NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CCGXP1998-05-18
1242451051898018K973240SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATIONHTY1997-11-20
1242452024461820K973018SYNTHES MINI LENGTHENING APPARATUSMQN1997-11-10
1242451857553859K973017SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIPKTT1997-10-16
1242451056749980K972516SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEMJDS1997-09-04
1242451163573533K971987SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORJEY1997-06-24
77381277512265K971883SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMKWQ1997-10-16
1242451277512265K971883SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMKWQ1997-10-16
1242451178536798K971783SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEMHTY1997-07-18
1242451365910962K970733SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEMHTY1997-04-02
77381365910962K970733SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEMHTY1997-04-02
77382034641955K970097PROXIMAL FEMORAL NAIL (PFN) SYSTEMJDW1997-03-13
1242452034641955K970097PROXIMAL FEMORAL NAIL (PFN) SYSTEMJDW1997-03-13
1242451266725808K970048SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)KWQ1997-08-01
77382062506455K964416SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEMKWQ1997-03-17
1242452062506455K964416SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEMKWQ1997-03-17
1242451777898131K964328SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATEJEY1996-12-13
1242451429862248K964261SMF STAINLESS STEEL BONE SCREWSDZL1997-04-11
1242451785754183K964259SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATIONJDO1997-01-09
1242451142578913K963798SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEMHRS1996-11-27
77381343905655K963618SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)LXT1996-11-12
1242451343905655K963618SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)LXT1996-11-12
1242451651579765K963546SMF TITANIUM (TI) ALLOY BONE SCREWSDZL1997-06-24
77381107195519K963357MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STEMNH1997-01-09
1242451107195519K963357MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STEMNH1997-01-09
1242451945648344K963325SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEMHRS1997-03-25
1242451977116083K963192SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWSHWC1996-11-08
1242451177443323K963172SYNTHES STERILE 4.5 MM CANNULATED SCREWSHWC1996-11-08
77381300642532K963045SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEMMNH1997-02-13
1242451300642532K963045SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEMMNH1997-02-13
1242451230152201K962913SYNTHES STERILE DRILL BITSHWE1996-11-14
1242451080653465K962894SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEMHRS1996-12-17
1242451863984346K962823SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHERHWC1996-10-01
1242451410252721K962616SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEMHRS1996-09-03
77381037620460K962608SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTORMNH1996-12-09
77381241181743K962484SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)KTT1996-09-05
1242451241181743K962484SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)KTT1996-09-05
1242451421474641K962272SYNTHES MANDIBLE DISTRACTORMQN1996-08-30
1242451458841525K962047TITANIUM CANNULATED TIBIAL NAIL (TI CTN)JDS1996-07-24
77381458841525K962047TITANIUM CANNULATED TIBIAL NAIL (TI CTN)JDS1996-07-24
1242451590238976K962011SYNTHES 7.0/7.3 MM CANNULATED SCREWSHWC1996-08-05
1242451499451803K961608SYNTHES (U.S.A.) POLYPINHTY1997-05-09
1242451728353571K961421SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEMJEY1996-06-26
1242451944340038K961413SYNTHES ANATOMICAL LOCKING PLATE SYSTEMHWC1996-08-07
1242451773315026K961350SYNTHES MINI EXTERNAL FIXATORKTT1996-06-28
1242451696341999K960782TITANIUM TUBE TO TUBE CLAMPJEC1996-05-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS1412026-03-10
JEY612020-09-10
KTT522026-06-11
HWC482019-11-26
KWQ402015-12-02
KWP362014-10-01
HSB352024-08-01
NKB242012-07-31
MQN212019-03-13
LXT202008-01-29
MNI182012-02-01
MQV162011-01-27
DZL162010-01-25
MNH152006-07-12
JDS142020-09-03
MQP142019-05-23
JDQ142018-06-21
JDR132020-02-26
HTN92020-04-06
HTY92014-01-09
GXP92010-09-23
KTW92008-03-20
GXR82013-08-16
OVE82012-07-25
GXN72025-11-12
MAX62015-06-18
MJO62007-12-17
JDW62004-04-12
GXQ52022-01-28
GWO52014-06-13
JDO51998-07-17
MBI42016-05-05
NDN42013-05-20
MTJ42011-12-13
HTO42011-08-10
JEC42007-08-24
LYC42006-01-23
HWE42005-01-05
KCT32025-03-28
FTM32019-03-13

PMN#