FDA.reportPublic FDA data

DePuy Synthes Products, Inc.

Matched from indexed company URL: DePuy Synthes

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30099968083009996808DePuy Synthes Products, Inc.1Y2026-01-01325 Paramount Drive Raynham MA US 02767
30251104393025110439DePuy Synthes West Palm Beach1N2026-01-01374 N Haverhill Rd Ste 400 West Palm Beach FL US 33415
30346767203034676720DePuy Synthes Sales1N2026-01-0175 Fruit St Bridgewater MA US 02324

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3348341184357412K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
3348341984599299K983485SYNTHES 1.3 MM SELF-DRILLING SCREWDZL1998-12-21
3348341519944925K982732SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)HRS1998-10-08
3348341271270583K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMHWC1998-07-29
3348341448444230K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
3348341324113405K981275SYNTHES (USA) RATCHETING DISTRACTORMQN1998-06-25
3348341840575767K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
3348342006021350K974555SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)JEY1998-03-03
3348341954031127K974537SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEMKTT1998-02-18
3348341163573533K971987SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORJEY1997-06-24
3348341178536798K971783SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEMHTY1997-07-18
3348341365910962K970733SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEMHTY1997-04-02
3348342034641955K970097PROXIMAL FEMORAL NAIL (PFN) SYSTEMJDW1997-03-13
3348341429862248K964261SMF STAINLESS STEEL BONE SCREWSDZL1997-04-11
3348341785754183K964259SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATIONJDO1997-01-09
3348341343905655K963618SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)LXT1996-11-12
3348341651579765K963546SMF TITANIUM (TI) ALLOY BONE SCREWSDZL1997-06-24
3348341945648344K963325SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEMHRS1997-03-25
3348341977116083K963192SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWSHWC1996-11-08
3348341177443323K963172SYNTHES STERILE 4.5 MM CANNULATED SCREWSHWC1996-11-08
3348341863984346K962823SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHERHWC1996-10-01
3348341410252721K962616SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEMHRS1996-09-03
3348341458841525K962047TITANIUM CANNULATED TIBIAL NAIL (TI CTN)JDS1996-07-24
3348341590238976K962011SYNTHES 7.0/7.3 MM CANNULATED SCREWSHWC1996-08-05
3348341854004362K954385SYNTHES MANDIBULAR MODULAR FIXATION SYSTEMJEY1996-03-08
3348341440855168K953806SYNTHES (USA) MIDFACIAL SYSTEMJEY1996-03-08
3348341085866931K953644VOLAR DISTAL RADIUS PLATEHRS1996-03-08
3348341615228679K952296SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREWHWC1995-08-18
3348342067940317K950384SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATORLXT1995-05-22
3348341871007237K935262P.F.C. TOTAL KNEE SYSTEM OVAL PATELLAJWH1994-06-03
3348341298210080K926453SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATEKWQ1993-10-12
3348341191821621K925351SYNTHES(U.S.A.) ANTERIOR SPINAL PLATEKWQ1993-11-05
3348341211493592K923613SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANTJDO1993-06-22
3348341031351735K914546ANGLED BLADE PLATEKTW1991-11-29
3348341645811734K912932SYNTHES MAXILLOFACIAL TITANIUM MICRO SETHRS1991-09-25
3348341480126600K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
3348341368713209K792291SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATESKTW1979-12-06
3348341298353568K792253ARICULATED TENSION DEVICE SYNTHES TENHWN1979-12-05
3348341821485434K791619DYNAMIC HIP SCREWKTT1979-08-28
3348341880878796K241927Synthes Graphic Case & Tray SystemKCT2025-03-28
3115141023042194K240211VELYS Robotic-Assisted SolutionOLO2024-06-05
3348341987196334K233967DePuy Synthes MatrixSTERNUM Fixation SystemHRS2024-05-09
3348341788507010K233696DePuy Synthes Retrograde Femoral Nail Advanced SystemHSB2024-08-01
3348341542165745K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating SystemHRS2024-03-21
3115141950169533K233228Spine Navigation and Robotic-Assistance DeviceOLO2024-06-14
3115141098989963K233227VELYS™ Robotic-Assisted SolutionOLO2023-12-14
3348341938002983K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemKTT2023-07-26
3348341231565385K230951Terumo Injection Filter Needle (NF-3013RBKE05M)QYM2023-10-18
3348341843287040K230591TriLEAP Plating SystemHRS2023-09-29
3348342017898096K221809DePuy Synthes 3.5mm Intrapelvic Acetabular SystemHRS2022-09-20
3348341188370519K212943SyntheCel Dura RepairGXQ2022-01-28
3348341299361083K211657EMPHASYS Femoral StemsLZO2021-08-05
3348341639172602K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)HRS2021-06-02
3348341180498757K210408DePuy Synthes Variable Angle Locking Patella Plating SystemHRS2021-04-08
3348341491448105K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemHRS2021-03-26
3348341114851733K203414DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate SystemHRS2020-12-16
3348341109985563K202810AutoStrut G2KTT2021-01-06
3115141001970963K202769VELYS™ Robotic-Assisted SolutionOLO2021-01-14
3348341606398965K201944DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)JEY2020-09-10
3348341691900064K201578DePuy Synthes Variable Angle Locking Patella Plating SystemHRS2020-09-09
3348341952437334K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mmHSB2020-09-23
3348341905052743K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmJDS2020-09-03
3348341129589299K192745DePuy Synthes Trauma ScrewsHWC2019-11-26
3348341734860721K192646SYMPHONY™ OCT SystemNKG2020-04-02
3348341886088835K191463DePuy Synthes Hammertoe Continuous Compression ImplantJDR2020-02-26
3348341890750433K190750DePuy Synthes Plates and Screws PortfolioHRS2019-06-21
3348341704055397K190409MatrixRIB Fixation SystemHRS2019-05-03
3348341093728587K183618Revolution Radial HeadKWI2019-05-17
3348341137613386K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalMQN2019-03-13
3348341592371187K181933DePuy Synthes Sterilization Container SystemKCT2019-05-09
3348341842214122K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsHWC2018-11-21
3348341322133940K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsHRS2018-11-01
3348341330869456K173550Akros FibuLink™ Syndesmosis Repair KitHTN2017-12-14
3348341141403097K172872DePuy Synthes Femoral Neck SystemKTT2018-03-05
3348341512967963K172157DePuy Synthes Femoral Recon Nail SystemHSB2017-11-14
3348341457264048K170802TRAUMACEM™ V+ Injectable Bone CementLOD2017-09-28
3348341098021431K162594Craniomaxillofacial Distraction System (CMFD)MQN2017-05-08
3348341572953188K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning PinsJDP2017-03-29
3348341879494546K161616DePuy 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
3348341082645334K161590MatrixRIB Fixation SystemHRS2016-11-03
3348341212715777K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT2016-11-10
3348341494951688K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless SHRS2017-06-30
3348341648329377K160167DePuy Synthes TFNA Augmentation SystemHSB2016-09-26
3348341829454142K153587Taps for Resorbable ScrewsHBG2017-01-18
3348341490824260K153575Tyber Medical Trauma ScrewHWC2016-02-26
3348341841782790K150796Dental Bone Cutting InstrumentsDZJ2015-06-23
3348341623206880K150125Elite Nitinol Fixation SystemJDR2015-05-11
3348341618610345K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)HRS2015-03-23
3348341201991652K142292Speed, Speed Shift, Speed Titan, Speed ArcJDR2014-11-17
3348341895379198K141796DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEMHRS2014-08-29
3348341150694232K141527DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEMHRS2015-03-30
3348341949083169K141385DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)HBW2015-03-27
3348341810850427K141165MATRIXWAVE MMF SYSTEMJEY2014-10-17
3348341404792497K140462MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)GWO2014-06-13
3348342048569314K133844SPEED TRIADJDR2014-04-07
3348342005221616K133842TYBER MEDICAL TRAUMA SCREWHWC2014-03-20
3348342028639805K133520HAMMERLOCK 2HTY2014-01-09
3348341810787950K131548SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEMHSB2014-02-28
3348341676100690K131186SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEMHRS2013-10-08
3348341346584891K123723SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEMGWO2013-09-05
3348341964734331K122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMKTT2013-04-11
3348341603276571K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEHRS2012-07-06
3348341566346325K121502SYNTHES CURVILINEAR DISTRACTION SYSTEMMQN2012-08-23
3348341460061980K120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMHRS2012-06-18
3348341554675366K120807SYNTHES MULTILOC HUMERAL NAILING SYSTEMHSB2012-07-06
3348341465703800K120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)HRS2012-05-08
3348342048439033K120689SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEMHRS2012-06-04
3348341987222476K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMHRS2012-03-21
3348341888895940K1133642.7MM LCP ULNA OSTEOTOMY SYSTEMHRS2012-02-29
3348341014704846K113071SYNTHECEL DURA REPLACEMENT DEVICESGXQ2012-01-09
3348341067893192K112583SYNTHES CORTICAL SCREWSHWC2011-12-05
3348341016294091K112085SYNTHES LCP PEDIATRIC PLATE SYSTEMSHRS2011-11-17
3348341145604908K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTSJDS2011-12-05
3348341221863940K111230SYNTHES 3.5MM LOW PROFILE CORTICAL SCREWHWC2011-05-24
3348342045864036K110789SYNTHES STERNAL ZIPFIX SYSTEMJDQ2011-07-28
3348342000164595K1103544.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEMJDP2011-03-04
3348342038420983K1101252.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEMHRS2011-04-21
3348341083155425K1032432.4MM VA-LCP INTERCARPAL FUSION SYSTEMHRS2011-01-21
3348341135476945K103002SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEMHSB2011-03-02
3348341597918565K1026942.4MM VA-LCP DORSAL DISTAL RADIUS PLATESHRS2010-12-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS772024-05-09
HWC232019-11-26
JEY182020-09-10
KTT172023-07-26
HSB162024-08-01
MQN92019-03-13
JDS82020-09-03
DZL82004-08-19
OLO42024-06-14
JDR42020-02-26
LXT42004-02-20
KTW42001-09-06
HTY32014-01-09
KWQ32003-07-02
KCT22025-03-28
GXQ22022-01-28
JDP22017-03-29
GWO22014-06-13
JDQ22011-07-28
NEI22008-09-05
JDW22004-04-12
JDO21997-01-09
QYM12023-10-18
LZO12021-08-05
NKG12020-04-02
KWI12019-05-17
HTN12017-12-14
LOD12017-09-28
HBG12017-01-18
DZJ12015-06-23
HBW12015-03-27
GXP12010-09-23
DZI12009-04-30
JEC12007-08-24
MQV12005-01-07
HWE12005-01-05
GXR12004-09-08
KWP12002-11-26
HTO12001-12-21
JWH11994-06-03

PMN#