BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Viant Medical, LLC

    Reg #: 3004976965 · FEI: 3004976965 · Expires 2026
    View on FDA
    Products
    56
    Proprietary Names
    165
    Establishment Types
    4
    Classifications
    56

    Registration Details

    Registration Name
    Viant Medical, LLC
    Registration Number
    3004976965
    FEI Number
    3004976965
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4545 Kroemer Rd
    City
    Fort Wayne
    State
    IN
    ZIP
    46818
    Country
    US

    Owner / Operator

    Firm Name
    Viant Medical, LLC
    Operator Number
    9043339
    Address
    2 Hampshire Street, Suite 202
    City
    Foxborough
    State
    MA
    Postal Code
    02035
    Country
    US
    Correspondent
    David - Rose

    Products

    Device Name Product Code
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Screwdriver HXX
    Orthopedic Stereotaxic Instrument OLO
    Forceps HTD
    Driver, Prosthesis HWR
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Chisel, Surgical, Manual FZO
    Pin, Fixation, Threaded JDW
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Shoulder Prosthesis, Reverse Configuration PHX
    Forceps, Wire Holding HYA
    Gauge, Depth HTJ
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Wrench HXC
    Reamer HTO
    Tap, Bone HWX
    Instrument, Cutting, Orthopedic HTZ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Guide, Surgical, Instrument FZX
    Orthopedic Manual Surgical Instrument LXH
    Cannula, Surgical, General & Plastic Surgery GEA
    Table, Surgical With Orthopedic Accessories, Manual JEB
    Impactor HWA
    Instrument, Bending Or Contouring HXP
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Forceps, General & Plastic Surgery GEN
    Tape, Measuring, Rulers And Calipers FTY
    Extractor HWB
    Tray, Surgical, Instrument FSM
    Rod, Fixation, Intramedullary And Accessories HSB
    Retractor GAD
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Osteotome HWM
    Staple, Fixation, Bone JDR
    Elevator HTE
    Rasp HTR
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Dispenser, Cement KIH
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Template HWT
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Awl HWJ
    Prosthesis, Elbow, Constrained, Cemented JDC
    Trephine HWK
    Broach HTQ
    Clamp HXD
    Bender HXW
    Hemostat HRQ
    Bit, Drill HTW
    Hook, Bone KIK

    Proprietary Names

    2.4MM A/O DRIVE X-LOCK BLADE GRAFT RETAINMENT - 8-16MM Maverick Swivel Attachment Clamp Maverick 75MM Multi-Pin Maverick Combination Clamp Maverick 45MM Multi-Pin Maverick External Fixation System Maverick Swivel Clamp Maverick Mini Double-Pin Swivel Clamp Maverick Mini Swivel Clamp 6MM - 4MM TM Reverse Screw Drill Guide TM Reverse Depth Gauge Mini Glenoid Baseplate 10 Degree Central Hole Drill Gauge Depth Gauge Long Depth Gauge Short Depth Gage, Adjustable Assembly Mini Glenoid Baseplate Central Depth Gauge Medtronic Depth Gauge Screw Gauge Depth Gauge Assembly, Volt System DEPTH GAGE, 2MM SCREW Biomet Depth Gauge Stryker Height Gauge Tower - ARS10247 10MM Smart TSF Ratchet Wrench Attune Revision - Taper Separator Wrench PROXIMAL REAMER MONOBLOC SZ2 - (CHT) 3.5mm Locking Screw - 2.7 Head 70 mm 3.5mm Locking Screw - 2.7 Head 18 mm 3.5mm Locking Screw - 2.7 Head 30 mm 3.5mm Locking Screw - 2.7 Head 34 mm 3.5mm Locking Screw - 2.7 Head 42 mm 3.5mm Locking Screw - 2.7 Head 65 mm 3.5mm Locking Screw - 2.7 Head 40 mm 3.5mm Locking Screw - 2.7 Head 28 mm 3.5mm Locking Screw - 2.7 Head 26 mm 3.5mm Locking Screw - 2.7 Head 55 mm 3.5mm Locking Screw - 2.7 Head 24 mm 3.5 Lck T-Plate Tilt, 4 HL Head 3.5mm Locking Screw - 2.7 Head 48 mm 3.5mm Locking Screw - 2.7 Head 20 mm 3.5mm Locking Screw - 2.7 Head 10 mm 3.5mm Locking Screw - 2.7 Head 38 mm 3.5mm Locking Screw - 2.7 Head 46 mm 3.5mm Locking Screw - 2.7 Head 50 mm 3.5mm Locking Screw - 2.7 Head 16 mm 3.5mm Locking Screw - 2.7 Head 22 mm 3.5mm Locking Screw - 2.7 Head 8mm 3.5mm Locking Screw - 2.7 Head 44 mm 3.5mm Locking Screw - 2.7 Head 36 mm 3.5mm Locking Screw - 2.7 Head 14 mm 3.5mm Locking Screw - 2.7 Head 12 mm 3.5mm Locking Screw - 2.7 Head 60 mm 3.5mm Locking Screw - 2.7 Head 32 mm PERIARTICULAR LOCKING PLATE SYSTEM Attune Revision Notch Cut Guide - Size 1,2,9,10 TELIGEN Procedure Kit Pro TELIGEN System Navigation Ready Instruments TELIGEN Procedure Kit Inferior/Superior Drill and Screw Guide Double Ended Drill Guide, 1.5/2mm Mini Baseplate Drill Guide Tip Taper Mini Baseplate Drill Guide Taper Screw Gryphon X Drill Guide - Reusable - UPL Drill Guides VOLT System STK HRS Saw Guide - FTW K-WIRE SNIPPERS QuickPass Tendon Shuttle, Small/Large TELIGEN Port Adjuster Versys Hip System - Calcar Resection Guide Size 13,15,17 STK HRS Drop Rod - FTW Cannulated Retaining Screw - 3mm Hex Drive Teligen Table Mount Adapter Knob Teligen Table Mount Adapter Fork Teligen Table Mount Adapter, Hudson Saw Interface Cleaning Cap VELYS Robotic-Assisted Solution Accessories Saw Interface Left Array Set - Knee Device Array Interface Array Clamp Saw Interface Right Comprehensive Reverse Shoulder EMSYS Ace Imp Curved ATTUNE RP IMPACTORS - TIBIAL AND FEMORAL Foot Multi-Planar Bender Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set Interoperative X-Ray Ruler Adolescent Nail Conical Extraction Adaptor Persona Tibial/General Instrument Tray Superior Acetabular Retractor Curved Retractor Secondary Anterior Acetabular Retractor Wide Right Angle Retractor Narrow Right Angle Retractor Teligen Locking Arm Assembly LIT Single Pt Ret, Sharp/Wide Mini Postero Retractor #4B Tibial Retractor Soft Tissue Protector - Tube Blue Handle Curved Retractor Soft Tissue Protector - Paddle Mini Postero Retractor #7A Anterior Acetabular Retractor Retractor 3 VIPER PRIME Locking Post Assembly Posterior Acetabular Retractor S-Curved Retractor Double Ended Retractor LIT Offset Double Retractor Bent Right Inferior Acetabular / Piriformis Retractor TELIGEN Graft Delivery Cannula - Non-Navigated VERSA-DIAL HUMERAL HEAD PROSTHESIS EMSYS Inclination Guide ADPT REEF TRIAL STEM 26-18X325 BROACH AND TRIAL STEM HANDLE REEF TRIAL STEM 26-10X325 REEF TRIAL STEM 26-10X375 FORET D3.5 LG 260MM LATERIZD HUM HEAD TRL DIA 42+4 REEF TRIAL STEM 26-20X325 60-90mm Straight, R127 PDT Rod Template LATERIZD HUM HEAD TRL DIA 36+4 DRILL GUIDE PLATE REEF TRIAL STEM 26-12X375 REEF TRIAL STEM 26-12X225 REEF TRIAL STEM 26-16X375 REEF DRILLING GUIDE LEFT COUGAR LS LORDOTIC TRIAL 8-16MM REEF DRILLING GUIDE RIGHT DRILL GUIDE DIA .5MM DRILLBIT D5 LG190 REEF TRIAL STEM 26-20X275 Mini Glenosphere Baseplate Provisional HEX SCREWDRIVER 3.5 BONE TAMP REEF TRIAL STEM 26-16X225 STD HUM HED TRIAL DIA 36 REEF TRIAL STEM 26-18X275 REEF TRIAL STEM 26-14X325 90-130mm, R127 PDT Rod Template TRIAL CUP DIAM 44 MM KAR TRIAL STEM SIZE 20 TROCH.COMPONENT IMPAC. REEF STEM TRIAL HANDLE DRILL GUIDE D 3.5 TROCAR COUGAR LS PARALLEL TRIAL 6-16MM KAR TRIAL STEM SIZE 14 REEF TRIAL STEM 26-16X275 REEF TRIAL STEM 26-10X225 15 X 80mm Prov. Mod. Finned Stem REEF TRIAL STEM 26-10X275 REEF TRIAL STEM 26-16X325 Teligen Navigated Graft Delivery NEXEL T-HANDLE Stryker Height Gauge Clamp - ARS10246 - FTW Zimmer ZIMCLIP TRACTION ASSY ZIMMER TRACTION MINICLIP Slimfuse Plate Bender Plate Bender Multiplanar Bender Rod Bender for 5.5mm Rod, Quantum Spinal Rod System Plate Bender, Assembly SYMPHONY Navigation Drill Guide Adjustable Body Sharp Hook

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Device in the United States for Export Only