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
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
30035068833003506883SYNTHES (USA) LLC1N2020-04-2535 AIRPORT RD. HORSEHEADS NY US 14845

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
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
77372040373875P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
77382040373875P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
1242452040373875P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
77371979326789K994364SYNTHES BUTTON PLATEMBI2000-03-15
1242451979326789K994364SYNTHES BUTTON PLATEMBI2000-03-15
77371767473167K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
77381767473167K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
1242451677234597K994161SYNTHES BIORESORBABLE SUTURE ANCHORMAI2000-07-28
77371185275357K994121SMALL STATURE USSMNI2000-10-17
77381185275357K994121SMALL STATURE USSMNI2000-10-17
77391185275357K994121SMALL STATURE USSMNI2000-10-17
1242451185275357K994121SMALL STATURE USSMNI2000-10-17
1242451358240838K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMHTO2000-06-12
77371313223531K993314SYNTHES LIGHT GUIDEFQP1999-12-06
1242451313223531K993314SYNTHES LIGHT GUIDEFQP1999-12-06
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
77371056417625K992739CLICK'XMNH2000-02-08
77381056417625K992739CLICK'XMNH2000-02-08
77391056417625K992739CLICK'XMNH2000-02-08
77371270524458K992617HEX BUTTONHTN1999-10-27
1242451270524458K992617HEX BUTTONHTN1999-10-27
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
77371879920802K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
1242451879920802K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
1242451251875950K991860SYNTHES CRANIAL FLAP TWIST CLAMPGXN1999-07-20
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
77371353100319K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
77381353100319K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
1242451353100319K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
1242451347616384K991004SYNTHES QUICK LOCK IMF SYSTEMDYX1999-06-23
77371783983571K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
77381783983571K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
1242451783983571K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
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
77371468193880K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
1242451468193880K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
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
77371090452243K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
77381090452243K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
1242451090452243K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
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
1242451595461307K983766SYNTHES SYNMESHEZX1998-12-18
77371139268263K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
77381139268263K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
77391139268263K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
1242451139268263K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
77371984599299K983485SYNTHES 1.3 MM SELF-DRILLING SCREWDZL1998-12-21
1242451984599299K983485SYNTHES 1.3 MM SELF-DRILLING SCREWDZL1998-12-21
1242451216387647K983104NORIAN PERIODONTAL/DENTAL CEMENT (PDC)LYC1999-02-12
1471061216387647K983104NORIAN PERIODONTAL/DENTAL CEMENT (PDC)LYC1999-02-12
77371833747714K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
77381833747714K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
77391833747714K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
1242451833747714K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
77371519944925K982732SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)HRS1998-10-08
1242451519944925K982732SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)HRS1998-10-08
77371216956723K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
77381216956723K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
77391216956723K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
77371271270583K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMHWC1998-07-29
77381271270583K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMHWC1998-07-29
77391271270583K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMHWC1998-07-29
1242451271270583K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMHWC1998-07-29
77371833874342K981890SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATESJEY1998-08-18
77391833874342K981890SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATESJEY1998-08-18
1242451833874342K981890SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATESJEY1998-08-18
77371428712946K981757SYNTHES (USA) DHS HELIX SYSTEMJDO1998-07-17
77391428712946K981757SYNTHES (USA) DHS HELIX SYSTEMJDO1998-07-17
1242451428712946K981757SYNTHES (USA) DHS HELIX SYSTEMJDO1998-07-17
1242451218192818K981372SYNTHES 3.0 MM PC-FIX SYSTEMHWC1998-05-11
77371448444230K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
77391448444230K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
1242451448444230K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
77371324113405K981275SYNTHES (USA) RATCHETING DISTRACTORMQN1998-06-25
1242451324113405K981275SYNTHES (USA) RATCHETING DISTRACTORMQN1998-06-25
1242451065213091K981075SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEETMQN1998-06-22
77371351009053K980944SYNTHES SCHUHLI IMPLANT SYSTEMHTN1998-04-27
1242451351009053K980944SYNTHES SCHUHLI IMPLANT SYSTEMHTN1998-04-27
77371533029117K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
77381533029117K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
77371079679983K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
77381079679983K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
1242451079679983K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
77371784059792K980358SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEMKWP1998-04-16
77381784059792K980358SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEMKWP1998-04-16
1242451784059792K980358SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEMKWP1998-04-16
77371840575767K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
77391840575767K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
1242451840575767K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
77371940599450K974908SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATESHRS1998-03-18
1242451940599450K974908SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATESHRS1998-03-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS2842026-03-09
JEY1172020-09-10
KTT972023-07-26
HWC832019-11-26
KWQ702015-12-02
KWP662014-10-01
HSB632024-08-01
NKB402012-07-31
MNI372012-02-01
LXT342008-01-29
MQN332019-03-13
MQP292019-05-23
DZL292010-01-25
JDQ262018-06-21
MNH252006-07-12
JDS222020-09-03
MQV202011-01-27
KTW172008-03-20
JDR152020-02-26
OVE132012-07-25
HTN122020-04-06
HTY122014-01-09
MAX112015-06-18
GXR112013-08-16
GXP112010-09-23
JDW112004-04-12
GXN102025-11-12
JDO91998-07-17
GWO82014-06-13
MJO82007-12-17
HWE82005-01-05
GXQ72022-01-28
NDN72013-05-20
HTO72011-08-10
NEI62008-09-05
KCT52025-03-28
FTM52019-03-13
MBI52016-05-05
OVD52015-08-21
JEC52007-08-24

PMA#

PMN#

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