Viant Medical, LLC

FDA Device Registration & Listing · Fort Wayne, IN, US · Registration 3004976965

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
3004976965
FEI Number
3004976965
Entity Name
Viant Medical, LLC
City/State/Country
Fort Wayne, IN, US
Establishment Address
4545 Kroemer Rd, Fort Wayne, IN 46818, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Viant Medical, LLC (Owner Number: 9043339)
Owner / Operator Contact Address
2 Hampshire Street, Suite 202, Foxborough, MA 02035, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-12-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-14
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-01-21
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2020-01-21
HXX Screwdriver Orthopedic Class 1 888.4540 2018-12-11
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-08-23
HTD Forceps General, Plastic Surgery Class 1 878.4800 2018-12-14
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2018-12-14
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2018-12-14
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-12-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-14
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2022-08-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2022-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-12-14
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-12-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-14
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2018-12-13
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-12-13
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-12-13
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-12-13
HYA Forceps, Wire Holding General, Plastic Surgery Class 1 878.4800 2018-12-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-14
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2018-12-13
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-12-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-14
HXC Wrench Orthopedic Class 1 888.4540 2018-12-14
HTO Reamer Orthopedic Class 1 888.4540 2018-12-11
HWX Tap, Bone Orthopedic Class 1 888.4540 2018-12-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-14
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2024-06-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-12-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-07-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-14
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-12-11
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-12-14
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2016-09-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-07
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-12-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-12-14
JEB Table, Surgical With Orthopedic Accessories, Manual General, Plastic Surgery Class 1 878.4950 2013-07-24
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-08-18
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-07-30
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2020-07-30
HWA Impactor Orthopedic Class 1 888.4540 2018-12-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-14
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2021-11-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-07-22
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2018-12-14
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-12-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-14
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2018-12-13
HWB Extractor Orthopedic Class 1 888.4540 2018-12-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-14
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-12-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-12-14
GAD Retractor General, Plastic Surgery Class 1 878.4800 2017-10-18
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-12-14
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2018-12-14
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-14
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-12-14
HTE Elevator General, Plastic Surgery Class 1 878.4800 2018-12-14
HTR Rasp General, Plastic Surgery Class 1 878.4800 2018-12-14
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-12-14
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2018-12-14

Official Correspondent

David Rose

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Viant Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2954750 Viant Fremont, Inc FREMONT, CA, US
2244012 Viant Medical, Inc S Plainfield, NJ, US
3006194679 Viant Medical SUZHOU EPZ Co., Ltd JIANGSU PROVINCE, CN
3009493875 Viant Medical, Inc. Grand Rapids, MI, US
1832228 Viant AS&O Holdings, LLC Indianapolis, IN, 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
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004976965. Last updated year: 2026. Please use registration number 3004976965 when referencing this establishment in official correspondence.
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