FDA.reportPublic FDA data

SYNTHES (USA) LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
77391185275357K994121SMALL STATURE USSMNI2000-10-17
77391056417625K992739CLICK'XMNH2000-02-08
77391184357412K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
77391498205691K991407SYNTHES LOCKING CALCANEAL PLATESLXT1999-06-11
77391588402404K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
77391439673375K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
77391595461307K983766SYNTHES SYNMESHEZX1998-12-18
77391139268263K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
77391833747714K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
77391216956723K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
77391271270583K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMHWC1998-07-29
77391833874342K981890SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATESJEY1998-08-18
77391428712946K981757SYNTHES (USA) DHS HELIX SYSTEMJDO1998-07-17
77391448444230K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
77391840575767K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
77392006021350K974555SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)JEY1998-03-03
77391163573533K971987SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORJEY1997-06-24
77391178536798K971783SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEMHTY1997-07-18
77392034641955K970097PROXIMAL FEMORAL NAIL (PFN) SYSTEMJDW1997-03-13
77391777898131K964328SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATEJEY1996-12-13
77391785754183K964259SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATIONJDO1997-01-09
77391107195519K963357MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STEMNH1997-01-09
77391728353571K961421SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEMJEY1996-06-26
77391773315026K961350SYNTHES MINI EXTERNAL FIXATORKTT1996-06-28
77391854004362K954385SYNTHES MANDIBULAR MODULAR FIXATION SYSTEMJEY1996-03-08
77391440855168K953806SYNTHES (USA) MIDFACIAL SYSTEMJEY1996-03-08
77392067940317K950384SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATORLXT1995-05-22
77391939259325K932593ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAILHSB1994-03-10
77391645811734K912932SYNTHES MAXILLOFACIAL TITANIUM MICRO SETHRS1991-09-25
77391368713209K792291SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATESKTW1979-12-06
77391821485434K791619DYNAMIC HIP SCREWKTT1979-08-28
77391135876240K192327DePuy Synthes 2.4mm LCP Straight Wrist Plate, SterileHRS2019-11-07
77391886088835K191463DePuy Synthes Hammertoe Continuous Compression ImplantJDR2020-02-26
77392009070360K183054SYNMESH SystemMQP2019-05-23
77391212715777K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT2016-11-10
77391648329377K160167DePuy Synthes TFNA Augmentation SystemHSB2016-09-26
77391841782790K150796Dental Bone Cutting InstrumentsDZJ2015-06-23
77391026679283K142838Synapse Occipital-Cervical-Thoracic (OCT) SystemNKG2015-01-20
77391155623495K142460EXPEDIUM Spine System/Synapse SystemKWP2014-10-01
77391190706530K141897SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMKWP2014-09-25
77391810850427K141165MATRIXWAVE MMF SYSTEMJEY2014-10-17
77391810787950K131548SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEMHSB2014-02-28
77391676100690K131186SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEMHRS2013-10-08
77391002824403K122647SYNTHES PATIENT SPECIFIC PLATEJEY2013-02-28
77391964734331K122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMKTT2013-04-11
77391603276571K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEHRS2012-07-06
77391460061980K120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMHRS2012-06-18
77391465703800K120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)HRS2012-05-08
77391839462420K120275SYNTHES ACIS/VERTEBRAL SPACER CRODP2012-05-25
77391987222476K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMHRS2012-03-21
77391469917878K113567SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEMJEY2012-11-19
77391933131400K112689SYNTHES STERNAL FIXATION SYSTEMHRS2011-10-26
77391927102534K111540SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEMHRS2011-08-08
77391623723941K102656SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEMJEY2010-12-20
77391119311105K1015362.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEMHRS2010-09-15
77391637200321K100952MODIFICATION TO SYNTHES MATRIX SYSTEMNKB2010-08-05
77391217331501K100776SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEMHRS2010-08-03
77391918983836K093928SYNTHES 3.5MM QUADRILATERAL SURFACE PLATESHRS2010-03-29
77391763061342K093772SYNTHES STERNAL FIXATION SYSTEMHRS2010-03-29
77391329142296K093299SYNTHES ORTHODONTIC BONE ANCHOR SYSTEMOAT2010-12-16
77391786805107K092929SYNTHES MATRIX SYSTEMNKB2009-12-29
77391138242943K092609SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)HRS2009-11-17
77391384672581K091689SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MMKWP2009-07-10
77391282136940K091644SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATESHRS2009-12-23
77391993683279K091233SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATESJEY2009-12-11
77391895700140K090658SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONALKTT2010-03-03
77391355035916K090605CLAMPFIXNKB2009-11-06
77391205588273K090549SYNTHES SYNAPSE TRANSCONNECTORKWP2009-05-21
77391057323237K090047SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEMHRS2009-04-01
77391607507102K083388SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEMJEY2009-03-12
77391715127664K083213SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATESHRS2008-12-30
77391101108908K082807SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONSHRS2008-11-24
77392049345898K082650SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONALKTT2008-11-18
77391725535748K082625SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATESHRS2008-12-17
77391190574953K082572USS ILIOSACRAL, USS POLYAXIALNKB2008-11-24
77392042681496K081568ANTEGRA-TKWQ2008-09-02
77391631933176K081452SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEMHSB2008-07-18
77391901679455K080943SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWSHWC2008-04-23
77391579485863K080522SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATESHRS2008-05-23
77391895594220K073460SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATESHRS2008-02-21
77391292998658K073186SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEMHRS2007-12-17
77391840108187K072791ORACLE SPACER, OPAL SPACERMAX2007-12-26
77391978105354K071264SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULEHRS2007-07-09
77391832027821K071184SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEMHRS2007-06-22
77391531344853K070946SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATESHRS2007-06-06
77391709386488K070294SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADESHSB2007-03-01
77391882951224K063790THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEMJEY2007-04-16
77391192188915K063473SYNTHES ORTHODONTIC BONE ANCHOR SYSTEMOAT2007-03-08
77391732775959K063158SYNTHES ANTEGRA SYSTEMKWQ2006-11-14
77391361904635K062933SYNTHES ORACLE SPACERMQP2007-01-31
77391683264364K061973SYNTHES 3.5MM SPRING PLATEHRS2006-09-11
77391725047703K061940SYNTHES LCP ANKLE ARTHRODESIS PLATESHRS2006-09-08
77391363373280K052683SYNTHES (USA) STERNAL FIXATION SYSTEMHRS2005-12-05
77391504712512K052390SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSIONHRS2005-10-07
77391605160796K052151SYNTHES PANGEA MONOAXIAL SYSTEMNKB2005-12-07
77391603609465K052123SYNTHES PANGEA SYSTEMKWP2005-09-23
77391991990983K051049SYNTHES (USA) LOW-PROFILE WRIST FIXATORKTT2005-07-13
77391366202960K050646SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATESHRS2005-04-26
77391736250618K050631SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSIONLXT2005-04-11
77391572673776K050608SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEMJEY2005-05-18
77391635515830K050378SYNTHES MANDIBLE EXTERNAL FIXATORMQN2005-03-15
77391274914462K050110SYNTHES (USA) LCP MODULAR FOOT PLATESHRS2005-03-04
77391349800366K050041SYNTHES (USA) STERILE STERNAL FIXATION SYSTEMJDQ2005-02-25
77392023577187K043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMHWE2005-01-05
77391240825998K042986MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEMGXR2004-11-17
77391948828060K042895SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADESKTT2004-11-16
77392010384599K042377SYNTHES LOW PROFILE RECONSTRUCTION PLATESHRS2004-10-07
77391995732832K042365SYNTHES (USA) NEURO PLATE AND SCREW SYSTEMJEY2004-11-18
77391218053964K042355SYNTHES (USA) LCP WRIST FUSION PLATESHRS2004-10-27
77391193135960K042135SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)HSB2004-10-07
77391653558107K041911SYNTHES (USA) LCP CURVED PLATESKTT2004-09-08
77391231858614K040777LCP RADIAL HEAD PLATING SYSTEMHRS2004-06-18
77391353499405K040701SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWSHWC2004-06-15
77391316872909K040588SYNTHES (USA) 2.4 MM LCP WRIST PLATEHRS2004-05-07
77391988025517K040272SYNTHES (USA) CRANIOFACIAL PLATESJEY2004-02-23
77391641999464K040169SYNTHES MANDIBLE EXTERNAL FIXATORMQN2004-04-14
77391973161458K033618SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEMHSB2004-02-05
77391213034643K033556SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEMKTT2004-01-13
77391820008294K033158SYNTHES REPROCESSED EXTERNAL FIXATION DEVICESKTT2003-11-05
77391155178123K032534SYNTHES AFSNQW2004-04-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS492019-11-07
JEY202014-10-17
KTT152016-11-10
KWP92014-10-01
HSB82016-09-26
MNI82003-03-24
MQP62019-05-23
NKB52010-08-05
KWQ52008-09-02
HWC42008-04-23
LXT42005-04-11
KTW32001-08-02
OAT22010-12-16
MQN22005-03-15
JDQ22005-02-25
MNH22000-02-08
JDO21998-07-17
DZL21998-06-29
JDR12020-02-26
DZJ12015-06-23
NKG12015-01-20
ODP12012-05-25
MAX12007-12-26
HWE12005-01-05
GXR12004-11-17
NQW12004-04-01
JDS11999-09-23
EZX11998-12-18
HTY11997-07-18
JDW11997-03-13

PMN#