FDA Registration Active 🇺🇸 United States

Synthes (USA) Products LLC

Reg #: 3008812560 · FEI: 3008812560 · Expires 2026
Products
173
Proprietary Names
685
Establishment Types
3
Classifications
173

Registration Details

Registration Name
Synthes (USA) Products LLC
Registration Number
3008812560
FEI Number
3008812560
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
1301 Goshen Pkwy
City
West Chester
State
PA
ZIP
19380
Country
US

Regulatory Submissions

510(k) Number
K092609
PMA Number
P050010

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
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS
Orthosis, Spinal Pedicle Fixation MNI
Orthosis, Spondylolisthesis Spinal Fixation MNH
Appliance, Fixation, Spinal Interlaminal KWP
Appliance, Fixation, Spinal Intervertebral Body KWQ
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Rod, Fixation, Intramedullary And Accessories HSB
Screw, Fixation, Intraosseous DZL
Pin, Fixation, Smooth HTY
Plate, Bone JEY
Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
Cerclage, Fixation JDQ
Chisel, Surgical, Manual FZO
Cannula, Surgical, General & Plastic Surgery GEA
Washer, Bolt Nut HTN
Arthroscope HRX
Reamer HTO
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Retractor, Fiberoptic FDG
Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
Spinal Vertebral Body Replacement Device MQP
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
Instrument, Ligature Passing And Knot Tying HCF
Tray, Surgical, Instrument FSM
Plate, Cranioplasty, Preformed, Non-Alterable GXN
Pusher, Socket HXO
Tamp HXG
Nail, Fixation, Bone JDS
Instrument, Compression HWN
Dura Substitute GXQ
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Thoracolumbosacral Pedicle Screw System NKB
Twister, Wire HXS
Cutter, Surgical FZT
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction KKY
Orthosis, Spine, Plate, Laminoplasty, Metal NQW
Device, Fixation, Proximal Femoral, Implant JDO
Staple, Fixation, Bone JDR
Impactor HWA
Bone Cement LOD
Accessories, Arthroscopic NBH
Awl HWJ
Burr, Orthopedic HTT
Pin, Fixation, Threaded JDW
Cement, Bone, Vertebroplasty NDN
Software For Diagnosis/Treatment OSN
Curette HTF
Instrument, Bending Or Contouring HXP
Wax, Bone MTJ
External Mandibular Fixator And/Or Distractor MQN
Mesh, Surgical, Metal EZX
Holder, Needle; Orthopedic HXK
Methyl Methacrylate For Cranioplasty GXP
Intervertebral Fusion Device With Bone Graft, Cervical ODP
Cover, Limb IPM
Gouge, Surgical, General & Plastic Surgery GDH
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Crimper, Pin HXQ
Instrument, Cranioplasty Material Forming HBX
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Punch, Surgical LRY
Condylar Plate Fixation Implant JDP
Lock, Wire, And Ligature, Intraoral DYX
Mesh, Surgical FTM
Plate, Cranioplasty, Preformed, Alterable GWO
Mesh, Surgical, Polymeric FTL
Screwdriver HXX
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
Bur, Surgical, General & Plastic Surgery GFF
Blade, Saw, General & Plastic Surgery, Surgical GFA
Cranial Distraction System PBJ
Rasp HTR
Washer, Bolt, Nut, Non-Spinal, Metallic NDG
Catheter, Irrigation GBX
Exerciser, Powered BXB
Tape, Measuring, Rulers And Calipers FTY
Prosthesis, Condyle, Mandibular, Temporary NEI
Driver, Wire, And Bone Drill, Manual DZJ
Drill, Bone, Powered DZI
Spatula, Orthopedic HXR
Countersink HWW
Handle, Scalpel GDZ
Retractor GAD
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
Orthopedic Manual Surgical Instrument LXH
Cover, Burr Hole GXR
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Battery, Replacement, Rechargeable MOQ
Component, Traction, Invasive JEC
Tray, Surgical LRP
Bone Grafting Material, Synthetic LYC
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Elevator HTE
Scissors, General, Surgical LRW
Guide, Surgical, Instrument FZX
Kit, Surgical Instrument, Disposable KDD
Prosthesis, Intervertebral Disc MJO
Implant, Endosseous, Orthodontic OAT
Forceps, General & Plastic Surgery GEN
Posterior Cervical Screw System NKG
Gauge, Depth HTJ
Mallet HXL
Wire, Fixation, Intraosseous DZK
Motor, Surgical Instrument, Ac-Powered GEY
Mixer, Cement, For Clinical Use JDZ
Retention Device, Suture KGS
Rongeur HTX
Motor, Drill, Pneumatic HBB
Pliers, Surgical HTC
Prosthesis, Rib Replacement MDI
Bit, Surgical GFG
Stylet, Surgical, General & Plastic Surgery GAH
Filler, Bone Void, Calcium Compound MQV
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation OIS
Lamp, Operating-Room FQP
Spinal Channeling Instrument, Vertebroplasty OCJ
Hook, Surgical, General & Plastic Surgery GDG
Vessel Guard Or Cover OMR
Fastener, Plate, Cranioplasty HBW
Sacroiliac Joint Fixation OUR
Dispenser, Cement KIH
Bath, Incubators/Water, All JTQ
Regulator, Pressure, Gas Cylinder CAN
Device, Percutaneous, Biopsy MJG
Forceps HTD
Starter, Bone Screw HWD
Tap, Bone HWX
Needle, Aspiration And Injection, Disposable GAA
Apparatus, Traction, Non-Powered HST
Cutter, Wire HXZ
Syringe, Piston FMF
Dissector, Surgical, General & Plastic Surgery GDI
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
Clamp, Surgical, General & Plastic Surgery GDJ
Broach HTQ
Orthopedic Stereotaxic Instrument OLO
Neurological Stereotaxic Instrument HAW
Drills, Burrs, Trephines & Accessories (Manual) HBG
Instrument, Cutting, Orthopedic HTZ
Injector, Vertebroplasty (Does Not Contain Cement) OAR
Template HWT
Clamp HXD
Driver, Prosthesis HWR
Hook, Bone KIK
Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
Suture, Nonabsorbable, Synthetic, Polyester GAS
Osteotome, Manual GFI
Wrench HXC
Passer HWQ
Caliper KTZ
Bit, Drill HTW
Goniometer, Nonpowered KQW
Bender HXW
Single Use Instrument Tray OJV
Driver, Surgical, Pin GFC
Cable, Electrode IKD
Scalpel, One-Piece GDX
Osteotome HWM
Extractor HWB
Forceps, Wire Holding HYA
Passer, Wire, Orthopedic HXI
Trephine HWK
Chisel, Bone, Surgical EML
Screwdriver, Skullplate GXL
Probe HXB
Implant, Fixation Device, Spinal JDN
Monitor, Pressure, Intracompartmental LXC
Hammer, Surgical FZY

Proprietary Names

Synthes 3.5/4.5 Curved Narrow/Broad EXPEDIUM Spine System/Synapse System Synthes Thoracolumbar Spine Locking SYNTHES CERVIFIX/ AXON instrument instrument, surgical, orthopedic, ac-powered motor and accessory/attachment SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION RAPIDSORB PLUS SCREW SYSTEM SYNTHES ELASTIC INTRAMEDULLARY NAIL 1.3 & 1.5MM CONTOURABLE TITANIUM (T Zero-P VA MODULAR FOOT SYSTEM - 2.7 MM SYNTHS ONE-THIRD TUBULAR DCL PLATE DePuy Synthes (USA) 5mm / 7.3mm Crimp Positioning Pins – MR Conditional DePuy Synthes 3.5 mm Intrapelvic Acetabular System 2.7mm VA LCP Clavicle Plate System spine instrument SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM cannula Akros Fibulink Syndesmosis Repair Kit SYNTHES (USA) REAMER IRRIGATOR AS SYNTHES(U.S.A.) ANTERIOR SPINAL PLA SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM SYNTHES (USA) LATERAL ENTRY FEMORAL SYNTHES (USA) LOW-PROFILE WRIST FIX DEPUY SYNTHES SPINE DENS ACCESS SYSTEM retractor Radial Head Prosthesis SYNTHES ZERO-P VARIABLE ANGLE (VA) SYNTHES VERTEBRAL SPACER TI SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS) Synthes Hybrid External Fixator SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE SUTURE GRASPER TRAYS AND RACKS. VARIOUS TYPES OF CASES Synthes Cortex Screws SYNTHES CRANIAL FLAP TUBE CLAMP SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM SYNTHES WIRE MOUNT SYNTHES TITANIUM (TI) ALLOY HIGH TI pusher, socket Synthes 3.5mm VA-LCP Proximal Tibia Plate Tamp SYNTHES PROXIMAL HUMERAL NAIL ARICULATED TENSION DEVICE SYNTHES TEN SyntheCel 5/7.3 Crimp Positioning Pins SYNTHES (USA) 6.5 MM CANCELLOUS SCR ZERO-P NATURAL PLATE SYNTHES (USA) HYDROXYAPATITE (HA) C VA LCP Two-Column Volar Distal Radius Plate 2.4/2.7 mm, Extra-Long SPEEDBUTTON ANCHOR SYSTEM Synthes In-Situ Bender/Cutter SYNTHES MATRIX MIS RODS SYNTHES ANKLE ARTHRODESIS PLATE SYNTHES LCP PEDIATRIC PLATE SYSTEMS WIRE INSTRUMENT SET SYNTHES 3.9 MM PELVIC SCREWS SYNTHES (USA) LCP CURVED PLATES CrossTIE 3.5mm Locking Attachment Plates SYNTHES LOW PROFILE NEURO SYSTEM - SYNTHES (USA) LCP MODULAR FOOT PLAT cutter, surgical AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT SYNTHES TITANIUM ALLOY VOLAR DISTAL SYNTHES 1MM TI. CORTEX, SELF-DRILLING SCREWS Ankle Trauma SYNTHES LOCKING CALCANEAL PLATES SMF Resorbable Mesh and Sheets SYNTHES AFS SYNTHES (USA) SMALL ADJUSTABLE CLAM SYNTHES (USA) SYNTHES MMFS-ADJUSTAB DePuy Synthes MatrixSTERNUM Fixation System SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW) SYNTHES (USA) DDHS/DCS SYSTEM MODIF Staple Titanium Small Recon Plates IMPACTOR VARIOUS TYPES OF IMPACTORS SYNTHES TITANIUM MULTI-VECTOR DISTR TRAUMACEM™ V+ Injectable Bone Cement SYNTHES LCP PROXIMAL TIBIA PLATES L SYNTHES (USA) RIA SYSTEM Synthes Cervifix System Akros Suture Anchor Lisfranc Repair Kit SYNTHES MULTILOC HUMERAL NAILING SYSTEM MAXILLARY DISTRACTOR AWL Synthes USA RIA System Burr, Orthopedic SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] Akros Fibulink™ Syndesmosis Repair Kit Vertecem II MAXFRAME Autostrut SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM SYNAPSE SYSTEM SYNTHES (USA) 3.5/4.5MM LCP MEDIAL CURETTE SYNTHES SPINE PEDIATRIC ROD SYSTEM Rapid Resorbable Tack System SYNTHES 4 AND 5 MM LOCKING SCRE SYNTHES SACRAL BAR SYSTEM SYNTHES 2.4 MM CANNULATED SCREW SYNTHES TRANSLATING MAXILLARY DISTR SYNTHES SCHUHLI IMPLANT SYSTEM SYNTHES SIMPLE SMALL EXTERNAL FIXAT 3.5mm Distal Tibia T Plates SYNTHES HEMOSTATIC BONE PUTTY SYNTHES ANTEGRA SYSTEM 3.5/4.5 LCP w/ Expanded Indications Synthes Matrix System SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM SYNTHES (USA) DISTAL FEMUR PLATE (D SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM 3.7MM/5MM DYNAMIC LOCKING SCREW SYNTHES SYNMESH MatrixRIB Fixation System Suprapatellar STROPP SYNTHES 2.7 MM CANNULATED SCREW AND NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY ACIS/Vertebral Spacer CR SYNTHES 2 MM CRANIOFACIAL LOCKING PLATES Synthes Synsonic Ulna Nail System HEX BUTTON cover, limb GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY SYNTHES UNREAMED HUMERAL NAIL (URHN SYNFIX-LR SPACER SYNTHES (USA) EXTERNAL MULTI VECTOR MatrixMANDIBLE Reconstruction Plates ANGLED BLADE PLATE SYnthes XRL SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES Orthopedic manual surgical instrument Screw Selection Probe VERTEBRAL SPACER Synthes Falcon Spacers SYNTHES 3MM HEADLESS COMPRESSION SYNTHES CURVED RECONSTRUCTION PLATE SYNTHES (USA) CLAVICLE HOOK PLATES Punch, Surgical Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins AND LIGATURE INTRAORAL LOCK SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPL SYNTHES LARGE FRAGMENT DYNAMIC COMP SPL CRIMP SYSTEM Porous Polyethylene Implants Synthes Curvilinear Distraction System SYNTHES (USA) ORIBITAL MESH PLATES Synthes 3.5 Quadrilateral Surface P SCREWDRIVER SYNTHES (USA) ELASTIC INTRAMEDULLAR SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM DePuy Synthes Static Staples SPIKED WASHER SYNTHES STERILE DRILL BITS plate SYNTHES LCP ANKLE ARTHRODESIS PLATE Craniomaxillofacial Distraction System (CMFD) SYNTHES (USA) [SYNTHES] MMFS - 2 RASP SCHUHLI IMPLANT SYSTEM Synthes(USA) 3.5mm Low Profile Cortical Screw DePuy Synthes Trauma Screws Introduction/drainage catheter and accessories SYNTHES (USA) WRIST FUSION PLATES ( MOBILIMB-CPM UPPER/LOWER LIMB DEVICE DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional SYNTHES (USA) [SYNTHES} PERI-PROSTH SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM Synthes Large Ex Fix MR Conditional measuring SYNTHES RIB FIXATION SYSTEM SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM SYNTHES LOW PROFILE NEURO SYSTEM TENSION DEVICE SYNTHES (USA) NEW/STERIAL ORBITAL P MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM Synthes 90 Degree Screwdriver SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES SYNTHES (USA) RESORBABLE FIXATION SYSTEM PLASTIC SPATULA SYNTHES DISTRACTION OSTEOGENESIS SY SYNTHES COMBINATION CLAMP AND DYNAM Tomofix SYNTHES MINI LENGTHENING APPARATUS SYNTHES STERNAL ZIPFIX SYSTEM SYNTHES (USA) LARGE EXTERNAL FIXATI SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS Synthes Zero-P COUNTERSINK COUNTERSINK (MULTIPLE BRANDS) SYNTHES LCP DYNAMIC HELICAL HIP SYS dissector, surgical, general & plastic surgery SYNTHES TITANIUM DIASTAL FEMORAL NA HOHMANN RETRACTOR SYNTHES LCP DISTAL FEMUR PLATES SYNTHES (USA) 2.4 MM LCP WRIST PLAT OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS SYNTHES (USA) TITANIUM WIRE SYNTHES STERILE 3.5 MM AND 4 MM C VARIOUS TYPES OF MANUAL Manual surgical instrument SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM SYNTHES (USA) LCP PROXIMAL HUMERUS SYNTHES ADOLESCENT LATERAL ENTRY FE SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM SMF STAINLESS STEEL BONE SCREWS SYNTHES SYNEX SPACER SYSTEM DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE SYNTHES 3.5 MM LOW PROFILE PELVIC R SYNTHES (USA) 3.5 MM BROAD LCP & 4. SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM SYNTHES (USA) MIDFACIAL SYSTEM SYNTHES 4.5 MM TITANIUM LCP PROXIMA SYNTHES RESORBABLE CONTOURABLE MESH MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES SYNTHES (USA) 1/1.22 MM CRANIOFAC SYNTHES ANTERIOR CERVICAL LOCKING P CrossCLIP Implant System DynaFORCE MotoCLIP MAX DynaFORCE HiMAX MotoCLIP Superelastic Fusion System SYNTHES (USA) TROCHANTER STABILIZ SYNTHES (USA) (SYNTHES) LOW PROFI Synthes 3.5mm LCP Clavicle Plate Sy SUSA Resorbable Mesh and Sheets TRAUMAFIX (TM) EXTERNAL FIXATOR MAXFRAME Multi-Axial Correction System (Aka MAXFRAME) battery SYNTHES (USA) EXTERNAL FIXATION COM Trochanteric Reattachment Device SYNTHES LCP PROXIMAL HUMERUS PLATES CrossRoads Bone Screw DePuy Synthes T-PAL Ti Spacer Synthes MATRIXMANDIBLE SUBCONDYLAR DYNAMIC CONDYLAR SCREW OR D.C.S. Tray, Surgical Posteromedial Proximal Tibia Plate SMALL TITANIUM WRIST FUSION PLATE chronOS - ß-TCP - LPK HiMAX MotoCLIP SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM SYNTHES RECONSTRUCTIVE PLATES `Y` P SYNTHES ORACLE SPACER MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) Elevator screw SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES Surgical Scissors SYNTHES STAINLESS STEEL MODULAR HAN Guide, Surgical, Instrument VARIOUS TYPES OF GUIDES SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM 2.7/3.5 LCP Ant. Lat. Dist. Tibia P SYNTHES ANTERIOR CSLP SYSTEM Matrix CoCr Locking Cap SYNTHES (USA) NEURO PLATE AND SCREW Maxframe SYNTHES 3.5MM TITANIUM LCP PROXIMAL USS-LINE EXTENSION SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM drill kit CLAMPFIX SYNTHES 1.5MM TI BROW LIFT SCREW SYN VA LCP ELBOW SYS MEDIAL & POSTERLAT DISTAL HUMERUS PLT DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System PRODISC SYNTHES USS (10MM SIDE OPENING SCREWS Radial Head VOLAR DISTAL RADIUS PLATE SYNTHES HAMSTRING LOOP SYNTHES 1.5MM/2MM ORTHOGNATHIC MA SYNTHES (USA) PATIENT SPECIFIC CRAN ORTHODONTIC BONE ANCHOR SYSTEM SYNTHES EXTERNAL FIXATION DEVICES, SYNTHES (USA) 3.5MM CONICAL SCREWS forceps SYNTHES (USA) STERILE STERNAL FIXAT Synapse Occipital-Cervical-Thoracic (OCT) System SYNTHES LCP DIAPHYSEAL-METAPHYSEAL ADJUSTABLE LARGE FIXATOR SYSTEM gauge SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT SYNTHES 5/7.3 MM CANNULATED LOCKI Depuy Synthes Maxillofacial Portfolio - MR Conditional OPAL Spacer Oracle spacer, opal spacer SYNTHES 2 MM LOCKING PLATE SYSTEM UNIVERSAL FEMORAL NAIL SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION RAM SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLAT DePuy Synthes Trauma Orthopedic Plates And Screws SYNTHES HIGH TIBIAL OSTEOTOMY PLATE DePuy Synthes Sterilization Container System SYNTHES STERILE PINLESS EXTERNAL FIXATOR Depuy Synthes Retrograde Femoral Nail Advanced System and DePuy Synthes Locking Screws for Medullary Nails, 5 mm bur SYNTHES MINI EXTERNAL FIXATOR SYNTHES (USA) MODULAR MINI FRAGMENT SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES SYNTHES CANNULATED ANGLE BLADE PLAT SYNTHES (USA) TROCHANTER STABILIZAT DePuy Synthes Maxillofacial Portfolio - MR Conditional power SYNTHES CRANIOFACIAL PLATES SYNTHES CONTOURED SYNMESH SPACER CEMENT MIXING BOWL DePuy Synthes Variable Angle Locking Patella Plating System Retention Device, Suture Depuy Synthes Retrograde Femoral Nail Advanced System Mandible External Fixator - MR Conditional RONGEUR SYNTHES 3.5MM CORTEX SCREWS 2.7/3.5 VA-LCP Anterior Clavicle Plate Sytem DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile SYNTHES AIR PEN DRIVE (APD) SYSTEM OSSE-LIGN SYNTHES SMALL COBINATION CLAMP-MR SAFE SYNTHES CRANIAL PLATES SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS) 1.5mm Headless Comp. Screws SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD HAMMERLOCK 2 Synthes Synapse 4 System 80:20 Resorbable Polypin SYNTHES 4.5 MM LCP POSTEROLATERAL P SYNTHES CERVIFIX SYSTEM MatrixMandible Self-Drilling Screws Orthomesh SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM SYNTHES PEDIATRIC ROD SYSTEM MatrixWAVE MMF System SYNTHES (USA) VARIABLE ANGLE-LOCKIN SYNTHES (USA) MEDIAL DISTAL TIBIA P Synthes 2.4 LCP Vol. Col. Distal Ra TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) SYNTHES (USA) RATCHETING DISTRACTOR pliers SYNTHES (USA) CALVICLE HOOK PLATE Vertical Expandable Prosthetic Titanium Rib SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM SYNTHES (USA) RETROGRADE/ANTEGRADE MODIFICATION TO SYNTHES MATRIX SYSTEM SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACR SYNTHES (USA) LCP WRIST FUSION PLAT DEPUY SYNTHES MAXFRAME AUTOSTRUT System Matrix Sagittal screws SYNTHES MANDIBLE DISTRACTOR bit Synthes TFN Screw SYNTHES TITANIUM UNREAMED FEMORAL NAIL general, plastic surgery SYNTHES (USA) DHS HELIX SYSTEM SYNTHES ANATOMICAL LOCKING PLATE SYSTEM SYNTHES HEMOSTATIC BONE PUTTY (HBP) SYNTHES QUICK LOCK IMF SYSTEM Synthes Locking Hand Plates SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM SYNTHES STERILE 2.7 MM RECONSTRUCTI DePuy Synthes Plates And Screws Portfolio MR Conditional NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY SYNTHES MIRS SYNEX II 2.4mm VA LCP Volar DR Plates SYNFRAME CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP SYNTHES USS CONNECTORS SYNTHES VECTRA-ONE SYSTEM SYNTHES 7/7.3 MM CANNULATED SCREW SMF TITANIUM (TI) ALLOY BONE SCREWS SYNTHES (USA) MIDFACE DISTRACTOR SYNTHES STERNAL FIXATION SYSTEM SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST DePuy Synthes Femoral Neck System Spinal Channeling Instrument, Vertebroplasty Hook SYNFIX Evolution Secured Spacer System SYNTHES SCOUT VESSEL GUARD DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) SYNTHES BUTTON PLATE SYNTHES 6.5 MM CANNULATED SCREW SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES Synthes graphic case & tray system Synthes Sternal Fixation System LCP RADIAL HEAD PLATING SYSTEM SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEA PELVIC C-CLAMP SYNTHES FLEXNAIL Resorbable Cranial Clamp 2.4/2.7mm VA-LCP Forefoot/Midfoot SYNTHES (USA) STERNAL FIXATION SYST VOLT™ Proximal Humerus 3.5 Plating System SYNTHES (USA) RESORBABLE TACK SYSTEM dispenser spine fixation SYNTHES 2.4 MM TITANIUM (TI.) LOCKI SYNTHES (USA) STERILE ADJUSTABLE DI Titanium TomoFix Medial High Tibia Plate Anatomical WATER BATH TRAY SYNTHES (USA) [SYNTHES] MINI EXTERN SYNTHES METALLIC SPIKED WASHERS 4.5mm/6.5mm Headless Comp. Screws SYNMESH System SYNTHES PANGEA MONOAXIAL SYSTEM SYNTHES MANDIBULAR MODULAR FIXATION TITANIUM UNIVERSAL CLAMP Hammertoe Continuous Compression Implant SYNTHES MIDFACE DISTRACTOR SYNTHES TI-15 MO LOCKING DISTAL RAD Hammerlock Synthes Self-Drilling Schanz Screw DePuy Synthes TFNA Augmentation System SYNTHES (USA) 1.3 MM CRANIOFACIAL S bone grafting material Synthes Set Screw for Ti Trochanteric Fixation Nail (TFN) Depuy Synthes Femoral Neck System SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM SYNTHES (USA) CANNULATED TITANIUM H SYNTHES 4MM TITANIUM (TI.) LOCKIN REGULATORS SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM Device, Percutaneous, Biopsy MatrixORTHOGNATHIC Plating System SYNTHES (USA) IMF SCREWS SYNTHES OC FUSION AND SYNAPSE SYSTEMS BONE FORCEPS STANDARD SET SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES SYNTHES SCALLOPED DISTAL TIBIA PLAT Trauma Screw SYNTHES MATRIXMANDIBLE PLATE AND SC SYNTHES 1/1.2 MM PLUSDRIVE SCREWS Synthes 4.5mm VA-LCP Curved Condylar Plate System VBB SYSTEM 3.5 MM 90 CANNULATED LIMITED CONTAC Synthes Clampfix System bone screw TRS C-BVF SYNTHES TITANIUM EXTERNAL FIXATOR C DePuy Synthes Femoral Recon Nail System SYNTHES (USA) DISTAL RADIUS PLATE S tap SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION SYNTHES VECTRA-T SYSTEM Synthes Patient Specific Plates Aspiration blade CrossRoads Screw System traction SYNTHES CHRONOS COMPOSITE cutter, wire STRoPP SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT SYNTHES (USA) STERNAL RECONSTRUCTIO DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System SYNTHES USS CONNECTOR DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System SYNTHES (USA) LCP PROXIMAL FEMUR PL mandibular fiaxtion 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 PRODISC-C TOTAL DISC REPLACEMENT SYNTHES (USA) CRANIOFACIAL PLATES SYNTHES PILON PLATE SYNTHES CALCANEAL PLATE SYNTHES (USA) MODIFICATION TO STERN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES MATRIXRIB FIXATION SYSTEM Periarticular Prox Humerus Plates Bone Marrow Aspiration (BMA) Syringe DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY UNIVERSAL TIBIAL NAIL AND UNREAMED SYNTHES (USA) EPOCA SHOULDER PROSTH SYNTHES PANGEA SYSTEM SYNTHES MANDIBLE EXTERNAL FIXATOR SYNTHES STERILE 3 MM CANNULATED S CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM SYNTHES (USA) SPHERICAL WASHERS BROACH Synthes Navigable Pedicle Preparation Instruments DynaFORCE VERO DynaFORCE DynaFORCE MotoBAND Max MotoBAND CP 2.4MM CORTEX SCREW, SELF-TAPPING Drill Bits & Taps Synthes 1.5mm Mini Fragment LCP Sys DePuy Synthes Tibial Nail Advanced Injector, Vertebroplasty (Does Not Contain Cement) 4.5 VA-LCP Curved Condylar System SYNTHES (USA) TIBIAL NAIL SYSTEM EX SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS) bone filler SMALL STATURE USS SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM SYNTHES ZERO-P TITANIUM CANNULATED TIBIAL NAIL (TI SYNTHES TI-6AI-7NB UNREAMED FEMORAL POSITIONING PLATE WAGNER RESURFACE INSTRUMENT SET SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW SYNTHES LOCKING DISTAL RADIUS PLATI SYNTHES (USA) LCP DYNAMIC HELICAL H SYNTHES STERILE LOW PROFILE NEURO C clamp DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM DePuy Synthes Porous Polyethylene Implants And Titanium Wires Portfolio – MR Conditional ChronOS - GXP SYNTHES SYNMESH SPACER SYSTEM STERILE BUTTON PLATE SYNTHES 4 MM ADJUSTABLE CLAMP FOR VERO MotoBAND MotoBAND Max SYNTHES (USA) ELBOW HINGE FIXATOR SYNTHES (USA) LCP PROXIMAL FEMUR HO driver SYNTHES MODULAR FOOT SYSTEM SYNTHES (USA) PEDIATRIC LCP HIP PLA SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM Synthes Distraction Osteogenesis Sy Synthes (USA) 2.4 VA-LCP 2-Col Narr Synthes Craniofacial Plate & Screw hook TI. ALLOY 2 MM CORTEX SCREW BONE STAPLE(S) SYNTHES UNIVERSAL LOCKING TROCHANTE Cerclage, fixation Vertecem SYNTHES LCP PROXIMAL TIBIA PLATE SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM 2.7/3.5 LCP Distal Fibula Plates SYNTHES (USA) (SYNTHES) SINGLE VECT CMFD Mandible Synthes Oracle Plate 6.5mm Midfoot Fusion Bolt ePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) 3.5 MM LCP DISTAL HUMERUS SYSTEM USS Iliosacral and Polyaxial System Synthes Light Guide SYNTHES SPINE POSTERIOR CERVICAL/TH SYNTHES (USA) ELECTRIC PEN DRIVE SY MotoBAND CP DynaForce SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM osteotome, manual SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) SYNTHES (USA) 2.4/2.7 MM LOCKING FO Norian CRS ANTEGRA-T Titanium T-Plate SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM) DePuy Synthes 2mm Quick Insertion Screws appliance CLICK'X MONOAXIAL SCREWS AND HOOKS WRENCH SYNTHES TOMOFIX OSTEOTOMY SYSTEM SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION Passer SYNTHES PATIENT SPECIFIC CRANIAL/CR Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment Synthes Reprocessed External Fixati Rapid Resorb. Cranial Clamp Synthes Synapse Transconnector VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System Caliper VARIOUS TYPES AND INSTRUMENT SET FOR ANGLED BLADE ChronOS BMA SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE MatrixMANDIBLE Fine Pitch Screws DePuy Synthes Trauma Orthopedic Nail Implants SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) GONIOMETER SYNTHES CERVICAL VERTABRAE PLATES bender DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2 mm Plates and Screws) DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) System Synthes 7.3mm Cann. SCFE Screws MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System SYNTHES (USA) FLEXIBLE HUMERAL NAIL SYNTHES 3 MM PC-FIX SYSTEM TORQUE LIMITING ATTACHMENT Synthes SyntheCel Dura Replacement Devices SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR SYNTHES MAXILLOFACIAL TITANIUM MICR SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SY 2.7MM LCP ULNA OSTEOTOMY SYSTEM SYNTHES 1.3 MM SELF-DRILLING SCREW SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS PROXIMAL FEMORAL NAIL (PFN) SYSTEM SYNTHES 1MM TI. CORTEX, SELF-DRIL cable 4/2.5 MM SELF-DRILLING SCHANZ SCREW SYNTHES CRANIAL SPRING CLIP (CSC) Synthes Patient Specific Implants SYNTHES PROXIMAL TIBIA PLATING SYST Keel Lock TriMAX Implant System HiMAX Plus scalpel osteotome TomoFix Medial Distal Femur Plates SMALL FRAGMENT DYNAMIC COMPRESSION Norian Drillable SYNTHES ANTEROLATERAL CALCANEAL PLA INSTRUMENT SET FOR RE TruMatch Graft Cage - Long Bone Plate LOCKING CONDYLAR PLATE (LCP) SYSTEM SYNTHES MEDIUM EXTERNAL FIXATION SY SYNTHES STRAIGHT WRIST FUSION PLATE SYNTHES T-PAL SPACER SYNTHES (U.S.A.) POLYPIN SYNTHES EXTERNAL MIDFACE DISTRACTOR SYNTHES SYNCAGE EVOLUTION SPACER CrossRoads Screw 3.5mm LCP Hook Plate MotoCLIP/HiMAX Step Staple Implant System SUTURE PASSER WIRE PASSER trephine SYNTHES LOW PROFILE RECONSTRUCTION TI-6AL-7NB URTN SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIV SYNFIX-LR SYNTHES SPIRAL BLADE FOR HUMERAL NA DYNAMIC HIP SCREW Synthes 6 CoCr and CP Ti - 3 Rods CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD chisel REAMER MEDULLARY INSTRUMENT SET screwdriver, skullplate probe DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) SYNTHES BIORESORBABLE SUTURE ANCHOR SYNTHES 2.4 MM UNIVERSAL LOCKING PL SYNTHES 3.5 MM BROAD LC-DCP PLATES DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System SYNTHES HINDFOOT ARTHRODESIS NAIL S SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM arthoscopic accessories CANNULATED FEMORAL NAIL SYNTHES DORSAL DISTAL RADIUS PLATE SYNTHES LARGE COMBINATION CLAMP AND Synthes Universal Spinal System VARIOUS TYPES OF SPI SYNTHES 3.5MM SPRING PLATE Epoca Shoulder Prosthesis, HA Stems MIS Bunion Plating System MiniBUNION Plating System Dental Bone Cutting Instruments SYNTHES VECTRA SYSTEM SYNTHES (USA) COMPARTMENTAL PRESSUR Synthes MatrixMANDIBLE Preformed Reconstruction Plates TITANIUM TUBE TO TUBE CLAMP VARIOUS TYPES OF HAMMERS CrossTIE Instraosseous Fixation System 2.4mm VA-LCP Intercarpal Fusion System SYNTHES LCP DISTAL TIBIA PLATES DePuy Synthes MatrixNEURO Reconstruction Mesh

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device