Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1319429

FEI Number

1000120314

Entity Name

Viant AS&O Holdings, LLC

City/State/Country

ORCHARD PARK, NY, US

Establishment Address

3902 CALIFORNIA RD., ORCHARD PARK, NY 14127, 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

VIPER PRIME X-Tab 4.5X35MM Ti Rod EXPEDIUM COCR Rod, Pre-Lordosed EXPEDIUM Spinal Rod EXPEDIUM Ti Dual Diameter Rod Revolution Radial Head STORZ Microflow and Standard Phacoemulsification Needle Phaco Chop Needles Needle MICROFLOW 30 Degree Vitality Spinal Fixation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-03-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-03-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-12-12
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-12-12
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2018-12-12
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-12-12
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2018-12-12
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2018-12-12
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2020-06-23
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2023-12-01
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2018-12-12
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2023-12-01
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2023-11-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-15

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
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319429. Last updated year: 2026. Please use registration number 1319429 when referencing this establishment in official correspondence.