DePuy Synthes Sales

FDA Device Registration & Listing · Bridgewater, MA, US · Registration 3034676720

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3034676720
FEI Number
3034676720
Entity Name
DePuy Synthes Sales
City/State/Country
Bridgewater, MA, US
Establishment Address
75 Fruit St, Bridgewater, MA 02324, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
SYNTHES (USA) Products LLC / Medical Device Business Service (Owner Number: 2520274)
Owner / Operator Contact Address
1301 Goshen Parkway, --, West Chester, PA 19380, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K141796
PMA Number
N/A

All Registered 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, Staple 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 Staple 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 instrument 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 MatrixRIB Fixation System 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2012-08-28
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2009-04-14
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2002-05-20
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 2007-12-20
JEY Plate, Bone Dental Class 2 872.4760 2007-12-21
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2007-12-20
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2026-06-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-04-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-04-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-06-15
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-05-08
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-05-08
JEY Plate, Bone Dental Class 2 872.4760 2007-12-20
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2007-12-20
JEY Plate, Bone Dental Class 2 872.4760 2007-12-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2007-12-20
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2020-04-20
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2002-05-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-07-21
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2007-12-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2014-03-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-09-21
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2008-05-22
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2020-03-31
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2007-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-05-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-05-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
HWN Instrument, Compression Orthopedic Class 1 888.4540 2013-05-08
GWO Plate, Cranioplasty, Preformed, Alterable Neurology Class 2 882.5320 2013-11-08
GXR Cover, Burr Hole Neurology Class 2 882.5250 2013-11-08
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2011-10-28
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2001-10-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-20
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2020-04-20
HWA Impactor Orthopedic Class 1 888.4540 2006-04-20
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2020-10-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-10-20
NOV Anchor, Suture, Bone Fixation, Metallic Orthopedic Class 2 888.3030 2026-06-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-05-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-07-11
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2017-07-11
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2017-07-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-07-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-07-11
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2017-07-11
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-07-11
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2017-07-11
HWX Tap, Bone Orthopedic Class 1 888.4540 2001-10-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-05-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-21
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2008-04-30
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 1996-12-02
HXS Twister, Wire Orthopedic Class 1 888.4540 1996-07-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 1995-01-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-12-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-12-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-01-02
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2007-12-20
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-06-09
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2020-04-20
HTW Bit, Drill Orthopedic Class 1 888.4540 2007-05-25
GAD Retractor General, Plastic Surgery Class 1 878.4800 2002-05-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2007-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-03-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-03-22
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2020-02-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-02-26
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-02-26
JDP Condylar Plate Fixation Implant Orthopedic Class 2 888.3030 2020-02-26
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2020-02-26
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2020-02-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2009-03-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-06-16
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2026-06-16
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2007-12-21
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2013-05-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-11-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-11-11
HTF Curette General, Plastic Surgery Class 1 878.4800 1995-01-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-05-08
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-03-08
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2016-11-16
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-11-16
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2010-12-21
JEY Plate, Bone Dental Class 2 872.4760 2013-05-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-04
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2002-05-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
GXL Screwdriver, Skullplate Neurology Class 1 882.4900 2013-11-20
JEY Plate, Bone Dental Class 2 872.4760 2011-10-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-20
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-12-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-03-21
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2020-02-26
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2020-02-26
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2020-02-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2020-02-26
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-02-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-02-26
NDG Washer, Bolt, Nut, Non-Spinal, Metallic Orthopedic Class 2 888.3030 2020-02-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-02-26
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2010-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2007-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2006-04-20
EML Chisel, Bone, Surgical Dental Class 1 872.4565 1995-01-20
JEY Plate, Bone Dental Class 2 872.4760 2008-05-22
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2013-05-08
HBW Fastener, Plate, Cranioplasty Neurology Class 2 882.5360 2015-12-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-20
JEY Plate, Bone Dental Class 2 872.4760 2007-12-20
GXQ Dura Substitute Neurology Class 2 882.5910 2012-01-16
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-12-21
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2011-10-28
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2011-12-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2010-12-29
JTQ Bath, Incubators/Water, All Microbiology Class 1 866.2540 2006-04-20
JEY Plate, Bone Dental Class 2 872.4760 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-06-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-06-05
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2006-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-04-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-04-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-06-16
DZK Wire, Fixation, Intraosseous Dental Class 2 872.4880 2020-02-26
NEI Prosthesis, Condyle, Mandibular, Temporary Dental Class 2 872.4770 2020-02-26
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2020-02-26
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2020-02-26
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2020-02-26
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-07-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-07-09
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2007-12-21
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2007-12-20
JEY Plate, Bone Dental Class 2 872.4760 2007-12-20
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2026-06-16
FDG Retractor, Fiberoptic Gastroenterology, Urology Class 1 876.4530 2005-09-20
HXC Wrench Orthopedic Class 1 888.4540 1995-01-20
HXL Mallet General, Plastic Surgery Class 1 878.4800 1996-07-05
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2006-04-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-05-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-04-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-20
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2002-02-01
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2007-12-20
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-01-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-20
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-21
GXQ Dura Substitute Neurology Class 2 882.5910 2022-02-11
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2007-12-20
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2013-05-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-05-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-11-22
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2026-06-16
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2026-06-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-06-16
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2026-06-16
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2026-06-16
JEY Plate, Bone Dental Class 2 872.4760 2007-12-20
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1995-01-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-09
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2007-12-20
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2007-12-20
HWW Countersink Orthopedic Class 1 888.4540 2001-05-05
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2022-04-13
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2022-04-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2022-09-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-07-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-07-17
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2017-03-10
HWB Extractor Orthopedic Class 1 888.4540 1996-07-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-01-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2009-12-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-12-29
JEY Plate, Bone Dental Class 2 872.4760 2009-03-13
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2026-06-16
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2026-06-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-06-16
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2015-12-02
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2023-08-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-21
JEY Plate, Bone Dental Class 2 872.4760 2014-10-17
JDP Condylar Plate Fixation Implant Orthopedic Class 2 888.3030 2011-03-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-03-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-03-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2010-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2010-12-21
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2007-12-20
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2019-07-07
GXP Methyl Methacrylate For Cranioplasty Neurology Class 2 882.5300 2012-05-21
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2007-12-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2007-12-20
NEI Prosthesis, Condyle, Mandibular, Temporary Dental Class 2 872.4770 2013-05-08
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2020-06-05
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-06-05
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2020-06-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-06-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-06-05
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2007-12-21
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2019-10-17
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2020-04-20
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 1995-01-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-06-16
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2026-06-16
JEY Plate, Bone Dental Class 2 872.4760 2007-12-21
NEI Prosthesis, Condyle, Mandibular, Temporary Dental Class 2 872.4770 2013-05-08
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2007-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-07-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-07-09
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-12-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-20
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2007-12-20
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
QYM Ophthalmic Needle General Hospital Class 2 880.5570 2025-03-21
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2007-12-21
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2010-04-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2007-12-20
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2007-12-20
GWO Plate, Cranioplasty, Preformed, Alterable Neurology Class 2 882.5320 2014-06-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2026-06-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-06-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2010-12-21
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-03-21
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-03-21
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2025-03-21
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2025-03-21
LOD Bone Cement Orthopedic Class 2 888.3027 2017-09-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2007-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-21
HXW Bender Orthopedic Class 1 888.4540 2002-05-20
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-03-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-03-21
GXR Cover, Burr Hole Neurology Class 2 882.5250 2012-10-26
HBW Fastener, Plate, Cranioplasty Neurology Class 2 882.5360 2012-10-26
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2002-01-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-07-24
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2007-12-21
DZI Drill, Bone, Powered Dental Class 2 872.4120 2007-12-21
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2007-12-21
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2007-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-11-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2010-09-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2010-09-17
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2025-03-21
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2007-04-30
JEY Plate, Bone Dental Class 2 872.4760 2007-12-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2010-12-21
HWT Template Orthopedic Class 1 888.4800 2006-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
JEY Plate, Bone Dental Class 2 872.4760 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-10-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-12-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2007-12-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-08-02
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-02
JEY Plate, Bone Dental Class 2 872.4760 2007-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-01-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2009-01-14
JDP Condylar Plate Fixation Implant Orthopedic Class 2 888.3030 2009-01-14
HXQ Crimper, Pin Orthopedic Class 1 888.4540 2010-12-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-05-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-05-08
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2013-05-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-12-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2009-12-02
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2010-12-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-03-18
HTD Forceps General, Plastic Surgery Class 1 878.4800 2007-05-25
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2016-12-14
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2016-12-14
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-06-16
JEY Plate, Bone Dental Class 2 872.4760 2020-09-23
HXX Screwdriver Orthopedic Class 1 888.4540 1995-02-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-12-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-12-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-08-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SYNTHES (USA) Products LLC / Medical Device Business Service
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008812560 Synthes (USA) Products LLC West Chester, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033476 Howmedica Osteonics Corp. MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 2004-01-20
K172572 Stryker Stryker Upper-Face AXS screws and Mid-Face AXS screws 2017-10-31
K121589 Biomet Microfixation BIOMET MICROFIXATION FACIAL PLATING SYSTEM 2012-09-21
K984230 Osteogenics Biomedical, Inc. OSTEO-MESH TM-300 1999-02-04
K021618 Osteomed Corp. OSA RIGID INTERNAL FIXATION SYSTEM 2002-08-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2007 Bioplate Inc 2
Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Z-0008-2023 Synthes (USA) Products LLC 2
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

Registration Number Establishment Name Location
3015212339 Jabil Inc. (Brandywine) W Chester, PA, US
3008868758 EXEL INC. DBA DHL SUPPLY CHAIN (USA) Mooresville, IN, US
1057946 KLS-Martin L.P. Jacksonville, FL, US
3009887475 Complexus Medical Mishawaka, IN, US
3000270450 Synthes GMBH Selzach Solothurn, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034676720. Last updated year: 2026. Please use registration number 3034676720 when referencing this establishment in official correspondence.
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