FDA.reportPublic FDA data

DEPUY ORTHOPAEDICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30044643253004464325DEPUY ORTHOPAEDICS1Y2027-01-0150 SCOTLAND BLVD. BRIDGEWATER MA US 02324

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
38121494980439P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
38121748058025K994121SMALL STATURE USSMNI2000-10-17
38121537792186K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMHTO2000-06-12
38122067011537K993314SYNTHES LIGHT GUIDEFQP1999-12-06
38121470593845K993099BREMER HALO SYSTEM TITANIUM SKULL PINJEC1999-12-15
38121793537118K992898THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEMGZT1999-10-21
38121633313327K992616SDB CERCLAGE SYSTEMJDQ1999-10-27
38121908056498K984498SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEMKTT1999-02-18
38121792088776K984350VSP SYSTEMMNI1999-01-20
38121819331806K983766SYNTHES SYNMESHEZX1998-12-18
38121015244397K982483DEPUY MOTECH PEAK FIXATION SYSTEMHRS1998-09-14
38121512153758K982443DOC VENTRAL CERVICAL STABILIZATION SYSTEMKWQ1998-07-29
38121892558015K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
38121647515773K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
38121870159445K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
38121589810041K980485ISOLA SPINAL SYSTEMMNI1998-10-21
38121288525231K980368DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEMHRS1998-04-14
38121782930331K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
38121980781251K974554SYNTHES RESORBABLE FIXATION SYSTEMJEY1998-02-24
38121027216246K971987SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATORJEY1997-06-24
38121833062145K971682J-FX CERCLAGE SYSTEMLRN1997-06-27
38121571015956K971544SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)HWE1997-05-28
38122001781747K971248KANEDA SR ANTERIOR SPINAL SYSTEMKWQ1997-06-11
38121593335067K963618SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)LXT1996-11-12
38121699347753K963172SYNTHES STERILE 4.5 MM CANNULATED SCREWSHWC1996-11-08
38121797709326K962913SYNTHES STERILE DRILL BITSHWE1996-11-14
38121144975287K961350SYNTHES MINI EXTERNAL FIXATORKTT1996-06-28
38121508788215K955348TITANIUM MOSS MIAMI SPINAL SYSTEMKWP1996-02-16
38121134096847K954069ACE CERVICAL TRACTION HALOZS, TONGS & PINSHAX1995-10-12
38121789240884K950384SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATORLXT1995-05-22
38121710322241K943819ISOLA ANTERIOR SYSTEMKWQ1995-02-09
38121776902652K934557CONTROL CABLE SYSTEMJDQ1994-02-25
38122068359254K914558TRAUMAFIX (TM) EXTERNAL FIXATORKTT1992-01-16
38121260792004K900138MOTECH TITANIUM SURGICAL MESHEZX1990-03-20
38121725028736K882008ACE SCREW REMOVAL TREPHINEHWE1988-06-10
38121667735496K792352SYNTHES CERVICAL VERTABRAE PLATESKWQ1979-12-06
38121460953459K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemHRS2026-03-02
38121161868958K253178TRILEAP Plating SystemHRS2026-01-06
38121754797748K241927Synthes Graphic Case & Tray SystemKCT2025-03-28
38121159223572K233994VOLT™ Proximal Humerus 3.5 Plating SystemHRS2024-07-26
38121524073567K233967DePuy Synthes MatrixSTERNUM Fixation SystemHRS2024-05-09
38121168189236K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating SystemHRS2024-03-21
38121529839959K230591TriLEAP Plating SystemHRS2023-09-29
38121989906300K221809DePuy Synthes 3.5mm Intrapelvic Acetabular SystemHRS2022-09-20
38121265145607K213978TELIGEN SystemHRX2022-10-18
38121650800044K212943SyntheCel Dura RepairGXQ2022-01-28
38121596536304K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetOLO2022-05-05
38121948031630K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mmHSB2020-09-23
38121913357896K191463DePuy Synthes Hammertoe Continuous Compression ImplantJDR2020-02-26
38121292063656K183618Revolution Radial HeadKWI2019-05-17
38121291641508K181933DePuy Synthes Sterilization Container SystemKCT2019-05-09
38121654332011K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsHWC2018-11-21
38121042704413K173550Akros FibuLink™ Syndesmosis Repair KitHTN2017-12-14
38121999054394K173526SENTIO MMG Gen 2PDQ2018-04-05
38121358532481K173134SENTIO MMG Pedicle Access NeedlesPDQ2018-03-22
38121814228476K172157DePuy Synthes Femoral Recon Nail SystemHSB2017-11-14
38121669038730K171570Additional VIPER PRIME™ screws with fenestrationsNKB2017-08-31
38121820214604K170937VIPER PRIME navigated inserterOLO2017-09-14
38121162112080K170802TRAUMACEM™ V+ Injectable Bone CementLOD2017-09-28
38121533371117K170543VIPER PRIME™ Screws with FenestrationsNKB2017-05-04
38121692757182K162912VIPER PRIME™ additions to the VIPER® SystemNKB2016-12-08
38121303082317K162805Akros Fibulink Syndesmosis Repair KitHTN2017-01-10
38121862128185K161616DePuy 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
38121663810203K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT2016-11-10
38121293182474K160904Expedium Spine System, VIPER and VIPER 2 SystemsNKB2016-07-01
38121982369665K151885SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemNKG2015-09-03
38121891603407K150796Dental Bone Cutting InstrumentsDZJ2015-06-23
38121402223238K150125Elite Nitinol Fixation SystemJDR2015-05-11
38121608588091K142838Synapse Occipital-Cervical-Thoracic (OCT) SystemNKG2015-01-20
38121228837842K141897SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMKWP2014-09-25
38121813143524K141509ISOLA AND EXPEDIUM GROWING SPINE SYSTEMSPGM2014-08-22
38121129025046K141385DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)HBW2015-03-27
38121261948774K140927UNIVERSAL NAVIGATION INSTRUMENTSOLO2014-10-24
38121096505913K140759BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERALMAX2014-06-13
38122046490821K133616MATRIXRIB FIXATION SYSTEMHRS2014-05-02
38121373210645K133520HAMMERLOCK 2HTY2014-01-09
38122055806907K132324SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTKWQ2013-09-06
38121516123813K131792SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAYGXQ2013-12-16
38121254783132K131304SENTIO MMGPDQ2014-05-29
38121220286562K131186SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEMHRS2013-10-08
38121433549407K130877EXPEDIUM SPINE SYSTEMNKB2013-06-20
38121473919733K130720SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEMKCT2014-08-14
38121107616976K130146SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEMNDN2013-05-20
38121558123375K130123BASIC AND DOMINANT FLEX SUCTION PUMPSBTA2013-10-11
38121110521381K123359OVS1 VIDEO SYSTEMFCW2012-12-19
38121854264360K122861XTOOLHRX2012-12-07
38121084281886K122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMKTT2013-04-11
38121329075907K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSHAW2012-12-17
38121835633566K121020VIPER SYSTEMNKB2012-05-03
38121002275847K120966DEPUY PULSE LUMBAR CAGE SYSTEMMAX2012-07-03
38121759873393K120867VIPER AND EXPEDIUM NAVIGATED INSTRUMENTSOLO2012-09-20
38121371542425K120517DEPUY PULSE CERVICAL CAGE SYSTEMODP2012-04-26
38121466343274K113545VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HANGEI2012-02-27
38121148552569K113396DEPUY PULSE THORACOLUMBAR SCREW SYSTEMNKB2012-02-08
38122012427733K113273SPOTLIGHT ACCESS SYSTEMGZT2012-01-27
38121943301665K113071SYNTHECEL DURA REPLACEMENT DEVICESGXQ2012-01-09
38121404141836K112724DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEMKWQ2011-11-21
38121234409165K112583SYNTHES CORTICAL SCREWSHWC2011-12-05
38121958951661K112030SYNTHES RADIAL HEAD PROSTHESIS SYSTEMKWI2012-06-19
38121652555570K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTSJDS2011-12-05
38121147110497K111571VIPER SYSTEMSNKB2011-07-06
38121516563170K111437SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)HTO2011-08-10
38121643823601K111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMNKB2012-06-14
38121785969860K110694CONCORDE BULLET SPINAL SYSTEMMAX2011-10-11
38121283676498K103002SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEMHSB2011-03-02
38121783863022K102018NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTYGXP2010-09-23
38121631836714K101993VIPER SYSTEM, EXPEDIUM SYSTEMNKB2010-12-07
38121549179800K101933MODIFICATION TO:EXPEDIUM SPINE SYSTEMNKB2010-10-18
38122073382367K101923CONCORDE CURVE SYSTEMMAX2010-12-01
38121936363482K100992NEURALMASETN2010-09-24
38121633106393K100676SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALLHRS2010-04-08
38121665673621K093668SYNTHES MATRIX MIS RODSNKB2010-03-09
38121140266716K093361SYNTHES AIR PEN DRIVE (APD) SYSTEMHBB2010-04-14
38121466618679K092929SYNTHES MATRIX SYSTEMNKB2009-12-29
38121334814175K092190SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONSKTT2010-05-11
38122052279543K091499MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)FTM2009-10-22
38121201566240K090658SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONALKTT2010-03-03
38121078330412K090648VIPER 2 SYSTEMNKB2009-06-10
38121039459597K090605CLAMPFIXNKB2009-11-06
38122017514493K090241SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)HSB2009-06-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KTT182016-11-10
HRS172026-03-02
NKB172017-08-31
KWQ162013-09-06
MNI92007-06-08
KWP72014-09-25
HSB62020-09-23
MAX62014-06-13
MQP62008-01-25
HWC52018-11-21
JEY52007-02-27
OLO42022-05-05
HTO42011-08-10
MQV42007-10-23
LXT42005-04-11
HWE42005-01-05
KCT32025-03-28
GXQ32022-01-28
PDQ32018-04-05
GZT32012-01-27
HRX22022-10-18
JDR22020-02-26
KWI22019-05-17
HTN22017-12-14
NKG22015-09-03
JDS22011-12-05
ETN22010-09-24
FTM22009-10-22
JEC22007-08-24
MQN22005-03-15
JDQ21999-10-27
EZX21998-12-18
DZL21998-06-29
LOD12017-09-28
DZJ12015-06-23
HBW12015-03-27
PGM12014-08-22
HTY12014-01-09
BTA12013-10-11
NDN12013-05-20

PMN#