FDA Registration Active 🇺🇸 United States

DePuy Synthes Sales

Reg #: 3034676720 · FEI: 3034676720 · Expires 2026
Products
116
Proprietary Names
311
Establishment Types
1
Classifications
116

Registration Details

Registration Name
DePuy Synthes Sales
Registration Number
3034676720
FEI Number
3034676720
Status
Active
Expiry Year
2026
Initial Importer
No
Address
75 Fruit St
City
Bridgewater
State
MA
ZIP
02324
Country
US

Regulatory Submissions

510(k) Number
K121502

Owner / Operator

Firm Name
SYNTHES (USA) Products LLC / Medical Device Business Service
Operator Number
2520274
Address
1301 Goshen Parkway, --
City
West Chester
State
PA
Postal Code
19380
Country
US

Products

Device Name Product Code
External Mandibular Fixator And/Or Distractor MQN
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Chisel, Surgical, Manual FZO
Bit, Surgical GFG
Plate, Bone JEY
Staple, Fixation, Bone JDR
Plate, Fixation, Bone HRS
Screw, Fixation, Bone HWC
Gouge, Surgical, General & Plastic Surgery GDH
Nail, Fixation, Bone JDS
Rod, Fixation, Intramedullary And Accessories HSB
Appliance, Fixation, Spinal Intervertebral Body KWQ
Pin, Fixation, Smooth HTY
Cutter, Wire HXZ
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
Kit, Surgical Instrument, Disposable KDD
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
Instrument, Compression HWN
Plate, Cranioplasty, Preformed, Alterable GWO
Cover, Burr Hole GXR
Handle, Scalpel GDZ
Apparatus, Traction, Non-Powered HST
Impactor HWA
Anchor, Suture, Bone Fixation, Metallic NOV
Tap, Bone HWX
Tape, Measuring, Rulers And Calipers FTY
Blade, Saw, General & Plastic Surgery, Surgical GFA
Twister, Wire HXS
Pliers, Surgical HTC
Screw, Fixation, Intraosseous DZL
Bit, Drill HTW
Retractor GAD
Condylar Plate Fixation Implant JDP
Device, Fixation, Proximal Femoral, Implant JDO
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Curette HTF
Passer, Wire, Orthopedic HXI
Screwdriver, Skullplate GXL
Washer, Bolt Nut HTN
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Pin, Fixation, Threaded JDW
Washer, Bolt, Nut, Non-Spinal, Metallic NDG
Guide, Surgical, Instrument FZX
Chisel, Bone, Surgical EML
Component, Traction, Invasive JEC
Fastener, Plate, Cranioplasty HBW
Dura Substitute GXQ
Bath, Incubators/Water, All JTQ
Hammer, Surgical FZY
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Wire, Fixation, Intraosseous DZK
Prosthesis, Condyle, Mandibular, Temporary NEI
Implant, Endosseous, Orthodontic OAT
Needle, Suturing, Disposable GAB
Retractor, Fiberoptic FDG
Wrench HXC
Mallet HXL
Dispenser, Cement KIH
Sacroiliac Joint Fixation OUR
Burr, Orthopedic HTT
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Hook, Surgical, General & Plastic Surgery GDG
Countersink HWW
Software For Diagnosis/Treatment OSN
Clamp, Surgical, General & Plastic Surgery GDJ
Drills, Burrs, Trephines & Accessories (Manual) HBG
Extractor HWB
Driver, Wire, And Bone Drill, Manual DZJ
Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
Methyl Methacrylate For Cranioplasty GXP
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Instrument, Cutting, Orthopedic HTZ
Ophthalmic Needle QYM
Motor, Surgical Instrument, Ac-Powered GEY
Appliance, Fixation, Spinal Interlaminal KWP
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Hemi-, Femoral, Metal KWL
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Bone Cement LOD
Bender HXW
Posterior Cervical Screw System NKG
Cannula, Surgical, General & Plastic Surgery GEA
Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
Drill, Bone, Powered DZI
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
Light, Surgical, Fiberoptic FST
Hook, Bone KIK
Template HWT
Crimper, Pin HXQ
Tray, Surgical LRP
Forceps HTD
Screwdriver HXX
Probe HXB
Cerclage, Fixation JDQ
Orthopedic Manual Surgical Instrument LXH
Driver, Prosthesis HWR
Reamer HTO
Osteotome HWM
Trephine HWK
Instrument, Manual, Surgical, General Use MDM
Filler, Bone Void, Calcium Compound MQV
Syringe, Piston FMF
Battery, Replacement, Rechargeable MOQ
Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
Elevator HTE
Awl HWJ
Gauge, Depth HTJ
Caliper KTZ
Driver, Surgical, Pin GFC
Tamp HXG
Cutter, Surgical FZT
Arthroscope HRX
Tray, Surgical, Instrument FSM
Instrument, Bending Or Contouring HXP

Proprietary Names

Synthes Curvilinear Distraction System Synthes Distraction Osteogenesis Sy spine instrument bit SYNTHES (USA) [SYNTHES] MINI EXTERN SMALL FRAGMENT DYNAMIC COMPRESSION GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System SYNTHES LCP PROXIMAL TIBIA PLATE DePuy Synthes 4 Mm And 4.5 Mm Cortex Screws, DePuy Synthes 2.4 Mm Cannulated Screws, DePuy Synthes 3.5 Mm And 4 Mm C GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM SYNTHES (USA) CANNULATED TITANIUM H SYNTHES MULTILOC HUMERAL NAILING SYSTEM SYNTHES MATRIXMANDIBLE PLATE AND SC SYNTHES CANNULATED ANGLE BLADE PLAT SYNTHES (USA) NEURO PLATE AND SCREW SYNTHES(U.S.A.) ANTERIOR SPINAL PLA HAMMERLOCK 2 cutter, wire Trauma Screw ANGLED BLADE PLATE DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) System DePuy Synthes 3.5 mm Intrapelvic Acetabular System mandibular fiaxtion drill kit SYNTHES (USA) TROCHANTER STABILIZAT SYNTHES LCP PEDIATRIC PLATE SYSTEMS SYNTHES LCP DISTAL FEMUR PLATES TITANIUM CANNULATED TIBIAL NAIL (TI SYNTHES PROXIMAL HUMERAL NAIL ARICULATED TENSION DEVICE SYNTHES TEN DePuy Synthes MatrixNEURO Reconstruction Mesh dissector, surgical, general & plastic surgery traction SYNTHES 7/7.3 MM CANNULATED SCREW Staple IMPACTOR VARIOUS TYPES OF IMPACTORS DePuy Synthes Tibial Nail Advanced MITEK MICRO QUICKANCHOR Synthes(USA) 3.5mm Low Profile Cortical Screw MR Conditional tap SYNTHS ONE-THIRD TUBULAR DCL PLATE SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM SYNTHES (USA) 3.5/4.5MM LCP MEDIAL measuring blade WIRE INSTRUMENT SET SYNTHES (USA) 2.4/2.7 MM LOCKING FO pliers DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM Synthes 3.5mm LCP Clavicle Plate Sy SMF STAINLESS STEEL BONE SCREWS SYNTHES EXTERNAL FIXATION DEVICES, VARIOUS TYPES AND INSTRUMENT SET FOR ANGLED BLADE HOHMANN RETRACTOR SYNTHES 4.5 MM TITANIUM LCP PROXIMA SYNTHES LARGE FRAGMENT DYNAMIC COMP 2.4mm VA-LCP Intercarpal Fusion System DePuy Synthes Plates And Screws Portfolio 2.4mm VA LCP Volar DR Plates MITEK MINI QUICKANCHOR PLU DYNACORD Suture SYNTHES (USA) EXTERNAL FIXATION COM SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System CURETTE SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION DePuy Synthes Femoral Neck System DePuy Synthes TFNA Augmentation System SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES DePuy Synthes 2mm Quick Insertion Screws SUTURE PASSER WIRE PASSER SYNTHES (USA) LCP PROXIMAL HUMERUS screwdriver, skullplate SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SY SYNTHES STERILE 3 MM CANNULATED S PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER DePuy Synthes Trauma Screws SYNTHES LCP PROXIMAL HUMERUS PLATES SYNTHES (USA) MODULAR MINI FRAGMENT SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM SYNTHES (USA) RETROGRADE/ANTEGRADE VOLAR DISTAL RADIUS PLATE Guide, Surgical, Instrument VARIOUS TYPES OF GUIDES chisel plate SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) SYNTHES STAINLESS STEEL MODULAR HAN SYNTHES 2 MM LOCKING PLATE SYSTEM Synthes SyntheCel Dura Replacement Devices SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYNTHES SPIRAL BLADE FOR HUMERAL NA SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM Suprapatellar SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE WATER BATH TRAY SYNTHES (USA) MIDFACIAL SYSTEM SYNTHES MAXILLOFACIAL TITANIUM MICR MatrixRIB Fixation System VARIOUS TYPES OF HAMMERS SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM Mini Superhawk Suture Anchor System DePuy Synthes Maxillofacial Portfolio - MR Conditional SYNTHES 5/7.3 MM CANNULATED LOCKI Ankle Trauma SYNTHES ELASTIC INTRAMEDULLARY NAIL Synthes Craniofacial Plate & Screw GAB - NEEDLE, SUTURING, DISPOSABLE retractor WRENCH RAM Synthes Hybrid External Fixator SYNTHES (USA) DISTAL RADIUS PLATE S 3.5mm Distal Tibia T Plates 4.5mm/6.5mm Headless Comp. Screws SYNTHES (USA) HYDROXYAPATITE (HA) C dispenser SYNTHES 1.5MM/2MM ORTHOGNATHIC MA Synthes Large Ex Fix MR Conditional SYNTHES 6.5 MM CANNULATED SCREW SYNTHES LCP DIAPHYSEAL-METAPHYSEAL SyntheCel SYNTHES (USA) 1/1.22 MM CRANIOFAC Burr, Orthopedic SYNTHES (USA) LCP PROXIMAL FEMUR HO 6.5mm Midfoot Fusion Bolt DePuy Synthes Femoral Recon Nail System Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, GII QUICKANCHOR PLUS SYNTHES MANDIBULAR MODULAR FIXATION Hook DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System MODULAR FOOT SYSTEM - 2.7 MM 3.5 MM LCP DISTAL HUMERUS SYSTEM COUNTERSINK COUNTERSINK (MULTIPLE BRANDS) MAXFRAME Autostrut SYNTHES DORSAL DISTAL RADIUS PLATE CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY SYNTHES LOW PROFILE RECONSTRUCTION SYNTHES (USA) 3.5 MM BROAD LCP & 4. SYN VA LCP ELBOW SYS MEDIAL & POSTERLAT DISTAL HUMERUS PLT Drill Bits & Taps INSTRUMENT SET FOR RE 2.7mm VA LCP Clavicle Plate System Synthes 2.4 LCP Vol. Col. Distal Ra MatrixORTHOGNATHIC Plating System Dental Bone Cutting Instruments DEPUY SYNTHES MAXFRAME AUTOSTRUT System SYNTHES 3.5MM TITANIUM LCP PROXIMAL MatrixWAVE MMF System Synthes 4.5mm VA-LCP Curved Condylar Plate System SYNTHES RIB FIXATION SYSTEM SYNTHES 1.3 MM SELF-DRILLING SCREW Radial Head Prosthesis NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY SYNTHES ANTERIOR CERVICAL LOCKING P SYNTHES ADOLESCENT LATERAL ENTRY FE SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM DePuy Synthes Trauma Orthopedic Plates And Screws SYNTHES SIMPLE SMALL EXTERNAL FIXAT DePuy Synthes Sterilization Container System instrument SYNTHES 4MM TITANIUM (TI.) LOCKIN HEALIX ADVANCE Anchor with DYNATAPE Suture SYNTHES MIDFACE DISTRACTOR SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM SYNTHES MANDIBLE EXTERNAL FIXATOR SYNTHES LCP PROXIMAL TIBIA PLATES L SYNTHES TOMOFIX OSTEOTOMY SYSTEM LOCKING CONDYLAR PLATE (LCP) SYSTEM Terumo Injection Filter Needle (NF-3013RBKE05M) SYNTHES (USA) EXTERNAL MULTI VECTOR power SYNTHES CERVIFIX/ AXON SYNTHES (USA) RATCHETING DISTRACTOR MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) HEALIX ADVANCE Anchor with DYNACORD Suture SYNTHES (USA) 3.5MM CONICAL SCREWS EMPHASYS Femoral Stems TRAUMACEM™ V+ Injectable Bone Cement SYNTHES TITANIUM DIASTAL FEMORAL NA screw Posteromedial Proximal Tibia Plate LCP RADIAL HEAD PLATING SYSTEM bender SYMPHONY™ OCT System Rapid Resorb. Cranial Clamp cannula TomoFix Medial Distal Femur Plates SYNTHES (USA) ELECTRIC PEN DRIVE SY 2.7/3.5 VA-LCP Anterior Clavicle Plate Sytem LIGHT, SURGICAL, FIBEROPTIC hook SYNTHES (USA) MIDFACE DISTRACTOR SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE POSITIONING PLATE WAGNER RESURFACE INSTRUMENT SET SYNTHES (USA) VARIABLE ANGLE-LOCKIN SYNTHES TRANSLATING MAXILLARY DISTR SYNTHES (USA) TROCHANTER STABILIZ 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES SYNTHES (USA) LCP PROXIMAL FEMUR PL Depuy Synthes Retrograde Femoral Nail Advanced System MAXILLARY DISTRACTOR 4.5 VA-LCP Curved Condylar System Orthopedic manual surgical instrument 2.7MM LCP ULNA OSTEOTOMY SYSTEM Tray, Surgical Synthes 3.5/4.5 Curved Narrow/Broad SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS) Synthes Self-Drilling Schanz Screw BONE FORCEPS STANDARD SET Maxframe Responsive Arthroscopy Suture Anchor System ePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) SCREWDRIVER 3.5/4.5 LCP w/ Expanded Indications Tomofix probe Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins 3.5mm LCP Hook Plate Akros Fibulink™ Syndesmosis Repair Kit VARIOUS TYPES OF MANUAL Manual surgical instrument SYNTHES 2.4 MM CANNULATED SCREW SMF TITANIUM (TI) ALLOY BONE SCREWS SYNTHES 1/1.2 MM PLUSDRIVE SCREWS SYNTHES STERNAL ZIPFIX SYSTEM SYNTHES (USA) TIBIAL NAIL SYSTEM EX driver REAMER MEDULLARY INSTRUMENT SET Hammertoe Continuous Compression Implant SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM SYNTHES (USA) LATERAL ENTRY FEMORAL osteotome trephine SYNTHES 1.5MM TI BROW LIFT SCREW SYNTHES (USA) DDHS/DCS SYSTEM MODIF DePuy Synthes Variable Angle Locking Patella Plating System Synthes MATRIXMANDIBLE SUBCONDYLAR SYNTHES 3.5MM CORTEX SCREWS INSTRUMENT, MANUAL, SURGICAL, GENERAL USE ChronOS BMA DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2 mm Plates and Screws) battery SYNTHES STERNAL FIXATION SYSTEM SYNTHES (USA) IMF SCREWS Synthes graphic case & tray system Synthes Cortex Screws HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchor TriLEAP Plating System MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD SYNTHES 3.5 MM LOW PROFILE PELVIC R DePuy Synthes MatrixSTERNUM Fixation System accessories, photographic, for endoscope SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM SYNTHES LCP DISTAL TIBIA PLATES Depuy Synthes Retrograde Femoral Nail Advanced System and DePuy Synthes Locking Screws for Medullary Nails, 5 mm SYNTHES (USA) LCP WRIST FUSION PLAT Synthes 3.5mm VA-LCP Proximal Tibia Plate Synthes 90 Degree Screwdriver DYNATAPE Suture Synthes 1.5mm Mini Fragment LCP Sys 2.4/2.7mm VA-LCP Forefoot/Midfoot Elevator SYNTHES STERILE 3.5 MM AND 4 MM C CMFD Mandible SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES AWL SYNTHES MODULAR FOOT SYSTEM SYNTHES TITANIUM (TI) ALLOY HIGH TI SYNTHES (USA) LCP MODULAR FOOT PLAT SYNTHES RECONSTRUCTIVE PLATES `Y` P SYNTHES EXTERNAL MIDFACE DISTRACTOR gauge SYNTHES 4 AND 5 MM LOCKING SCRE Caliper Periarticular Prox Humerus Plates 3.5mm Locking Attachment Plates SYNTHES (USA) ELASTIC INTRAMEDULLAR 2.7/3.5 LCP Distal Fibula Plates SYNTHES (USA) DISTAL FEMUR PLATE (D TORQUE LIMITING ATTACHMENT SYNTHES (USA) [SYNTHES} PERI-PROSTH Synthes (USA) 2.4 VA-LCP 2-Col Narr DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) PROXIMAL FEMORAL NAIL (PFN) SYSTEM Tamp SYNTHES HINDFOOT ARTHRODESIS NAIL S SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM HEALIX ADVANCE KNOTLESS Anchor SYNTHES (USA) STERNAL RECONSTRUCTIO cutter, surgical SYNTHES (USA) REAMER IRRIGATOR AS DYNAMIC HIP SCREW SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM TRAYS AND RACKS. VARIOUS TYPES OF CASES GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor

Establishment Types

Repack or Relabel Medical Device