Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2954750

FEI Number

3003080271

Entity Name

Viant Fremont, Inc

City/State/Country

FREMONT, CA, US

Establishment Address

45581 Northport Loop W, FREMONT, CA 94538, 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PCSS IMPLANT, 4MM CORUS PCSS LEVELONE PCSS IMPLANT, 5MM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2026-02-10

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
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
1319429	Viant AS&O Holdings, LLC	ORCHARD PARK, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K173198	U&I Corporation	Facet Screw Fixation System	2018-01-03
K121850	Choicespine, LP	Typhoon(TM) Facet Screw Fixation System	2012-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2012	Osteomed, Lp 3885 Arapaho Rd Addison TX 75001	U	OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001

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3016443334	SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED	KADI Gujarat, IN
2647346	MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO	HUMACAO, PR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2954750. Last updated year: 2026. Please use registration number 2954750 when referencing this establishment in official correspondence.