Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615674

FEI Number

3002807479

Entity Name

Viant Chaumont S.A.S.

City/State/Country

CHAUMONT Haute-Marne, FR

Establishment Address

4 Rue Renee et Louis Landanger, CHAUMONT Haute-Marne 52000, FR

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PROXIMAL REAMER MONOBLOC SZ2 - (CHT) 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 Adolescent Nail Conical Extraction Adaptor DXTEND MODULAR HUM STEM D10 HA DXTEND MOD EPI 1 ECC RIGHT HA DXTEND MOD EPI 1 HA DXTEND MOD EPI 2 ECC LEFT HA DXTEND MODULAR HUM STEM D14 HA DXTEND MODULAR HUM STEM D12 HA DXTEND MODULAR HUM STEM D16 HA DXTEND MOD EPI 2 HA DXTEND MOD EPI 2 ECC RIGHT HA DXTEND MOD EPI 1 ECC LEFT HA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTO	Reamer	Orthopedic	Class 1	888.4540	2018-12-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-12-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-12-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-12-13
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2018-12-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-12-13
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2018-12-13
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2016-09-15
HWB	Extractor	Orthopedic	Class 1	888.4540	2018-12-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-12-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-11-14
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2024-11-14
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-12-13
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2018-12-13
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2018-12-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-12-13

Official Correspondent

David Rose

US Agent Details

David Rose Email: david.rose@viantmedical.com Phone: (480) 5536400

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
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615674. Last updated year: 2026. Please use registration number 9615674 when referencing this establishment in official correspondence.