FDA.reportPublic FDA data

SYNTHES USA PRODUCTS, LLC

Matched from indexed company URL: Synthes USA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30099968083009996808SYNTHES USA PRODUCTS, LLC1N2020-04-25325 Paramount Drive Raynham MA US 02767
30101973483010197348Synthes USA1N2020-04-251210 Ward Ave West Chester PA US 19380

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
1581901799236197P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1636752034302737P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1581902040373875P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1581901979326789K994364SYNTHES BUTTON PLATEMBI2000-03-15
1636751242400662K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
1581901767473167K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
1581901677234597K994161SYNTHES BIORESORBABLE SUTURE ANCHORMAI2000-07-28
1581901185275357K994121SMALL STATURE USSMNI2000-10-17
1636751292995323K994121SMALL STATURE USSMNI2000-10-17
1581901358240838K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMHTO2000-06-12
1581901313223531K993314SYNTHES LIGHT GUIDEFQP1999-12-06
1636751612491835K993314SYNTHES LIGHT GUIDEFQP1999-12-06
1581901510491167K992891SYNTHES CERCLAGE POSITIONING PINJDQ1999-11-02
1581901320717995K9928373.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)KTW1999-10-25
1581901056417625K992739CLICK'XMNH2000-02-08
1636751907678622K992739CLICK'XMNH2000-02-08
1581901270524458K992617HEX BUTTONHTN1999-10-27
1581901382361674K992616SDB CERCLAGE SYSTEMJDQ1999-10-27
1581901184357412K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
1581901879920802K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
1581901251875950K991860SYNTHES CRANIAL FLAP TWIST CLAMPGXN1999-07-20
1636751526952551K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
1581901786620850K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
1581901498205691K991407SYNTHES LOCKING CALCANEAL PLATESLXT1999-06-11
1581901353100319K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
1636751715412671K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
1581901347616384K991004SYNTHES QUICK LOCK IMF SYSTEMDYX1999-06-23
1636751253310120K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
1581901783983571K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
1636751004683311K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
1581901588402404K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
1581901468193880K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
1636751295348043K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
1581901439673375K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
1581901450745994K984498SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEMKTT1999-02-18
1581901090452243K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
1636751978190890K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
1581902072621255K983787SYNTHES PROXIMAL TIBIA PLATING SYSTEMHRS1999-01-21
1581901595461307K983766SYNTHES SYNMESHEZX1998-12-18
1636751853041958K983766SYNTHES SYNMESHEZX1998-12-18
1581901139268263K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
1636751263141144K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
1581901984599299K983485SYNTHES 1.3 MM SELF-DRILLING SCREWDZL1998-12-21
1636751625361453K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
1581901833747714K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
1581901519944925K982732SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)HRS1998-10-08
1581901216956723K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
1636751242958573K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
1581901271270583K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMHWC1998-07-29
1581901833874342K981890SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATESJEY1998-08-18
1581901428712946K981757SYNTHES (USA) DHS HELIX SYSTEMJDO1998-07-17
1581901218192818K981372SYNTHES 3.0 MM PC-FIX SYSTEMHWC1998-05-11
1581901448444230K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
1581901324113405K981275SYNTHES (USA) RATCHETING DISTRACTORMQN1998-06-25
1581901065213091K981075SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEETMQN1998-06-22
1581901351009053K980944SYNTHES SCHUHLI IMPLANT SYSTEMHTN1998-04-27
1636751123814477K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
1581901533029117K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
1581901079679983K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
1636751277829076K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
1636751040114027K980358SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEMKWP1998-04-16
1581901784059792K980358SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEMKWP1998-04-16
1581901840575767K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
1581901940599450K974908SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATESHRS1998-03-18
1581902006021350K974555SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)JEY1998-03-03
1581901098644880K974554SYNTHES RESORBABLE FIXATION SYSTEMJEY1998-02-24
1581901954031127K974537SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEMKTT1998-02-18
1581901403275692K974525SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEMKWQ1998-03-02
1636751756354778K974525SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEMKWQ1998-03-02
1581901184318858K974206SYNTHES CRANIAL SPRING CLIP (CSC)GWO1998-03-16
1581902016272455K973789NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CCGXP1998-05-18
1581901051898018K973240SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATIONHTY1997-11-20
1581902024461820K973018SYNTHES MINI LENGTHENING APPARATUSMQN1997-11-10
1581901857553859K973017SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIPKTT1997-10-16
1581901056749980K972516SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEMJDS1997-09-04
1581901163573533K971987SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORJEY1997-06-24
1581901277512265K971883SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMKWQ1997-10-16
1636751906685975K971883SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMKWQ1997-10-16
1581901178536798K971783SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEMHTY1997-07-18
1581901618380134K971544SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)HWE1997-05-28
1581901365910962K970733SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEMHTY1997-04-02
1581902034641955K970097PROXIMAL FEMORAL NAIL (PFN) SYSTEMJDW1997-03-13
1581901266725808K970048SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)KWQ1997-08-01
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
1581902062506455K964416SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEMKWQ1997-03-17
1581901777898131K964328SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATEJEY1996-12-13
1581901429862248K964261SMF STAINLESS STEEL BONE SCREWSDZL1997-04-11
1581901785754183K964259SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATIONJDO1997-01-09
1581901142578913K963798SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEMHRS1996-11-27
1581901343905655K963618SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)LXT1996-11-12
1581901651579765K963546SMF TITANIUM (TI) ALLOY BONE SCREWSDZL1997-06-24
1581901107195519K963357MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STEMNH1997-01-09
1636751282780061K963357MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STEMNH1997-01-09
1581901945648344K963325SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEMHRS1997-03-25
1581901977116083K963192SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWSHWC1996-11-08
1581901177443323K963172SYNTHES STERILE 4.5 MM CANNULATED SCREWSHWC1996-11-08
1581901300642532K963045SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEMMNH1997-02-13
1636752008822700K963045SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEMMNH1997-02-13
1581901230152201K962913SYNTHES STERILE DRILL BITSHWE1996-11-14
1581901080653465K962894SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEMHRS1996-12-17
1581901863984346K962823SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHERHWC1996-10-01
1581901410252721K962616SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEMHRS1996-09-03
1581901037620460K962608SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTORMNH1996-12-09
1636751741324864K962608SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTORMNH1996-12-09
1581901241181743K962484SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)KTT1996-09-05
1581901421474641K962272SYNTHES MANDIBLE DISTRACTORMQN1996-08-30
1581901458841525K962047TITANIUM CANNULATED TIBIAL NAIL (TI CTN)JDS1996-07-24
1581901590238976K962011SYNTHES 7.0/7.3 MM CANNULATED SCREWSHWC1996-08-05
1581901499451803K961608SYNTHES (U.S.A.) POLYPINHTY1997-05-09
1581901728353571K961421SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEMJEY1996-06-26
1581901944340038K961413SYNTHES ANATOMICAL LOCKING PLATE SYSTEMHWC1996-08-07
1581901773315026K961350SYNTHES MINI EXTERNAL FIXATORKTT1996-06-28
1581901696341999K960782TITANIUM TUBE TO TUBE CLAMPJEC1996-05-08
1581901866657643K960269TITANIUM UNIVERSAL CLAMPLXT1996-04-04
1581902021747986K954963SCHUHLI IMPLANT SYSTEMHRS1996-03-22
1581901329704138K954856CANNULATED FEMORAL NAILJDN1996-03-08
1581901854004362K954385SYNTHES MANDIBULAR MODULAR FIXATION SYSTEMJEY1996-03-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS1112019-05-03
KWQ552015-12-02
JEY422014-10-17
KWP412014-10-01
KTT352018-10-16
HWC352013-12-16
NKB292017-03-29
HSB282017-11-14
MNI252012-02-01
MQP212011-10-20
MNH162006-07-12
MQN152017-05-08
LXT142008-01-29
DZL132010-01-25
MAX122018-12-06
JDQ122011-07-28
JDS112011-12-05
OVE102012-07-25
MQV92011-01-27
KTW82008-03-20
NDN72013-05-20
HTN62002-02-08
OVD52015-08-21
MJO52007-12-17
JDW52004-04-12
HTY52001-04-09
JDO51998-07-17
GWO42014-06-13
HTO42011-08-10
GXP42010-09-23
JEC42007-08-24
GXN42005-12-14
OMR32012-06-14
NEI32008-09-05
HWE32005-01-05
GXR32004-11-17
JDR22020-02-26
NKG22015-01-20
MDI22014-11-18
GXQ22013-12-16

PMN#