Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1218882

FEI Number

1218882

Entity Name

Viant AS&O Holdings, LLC

City/State/Country

Brimfield, MA, US

Establishment Address

68 MILL LN. RD., Brimfield, MA 01010, 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

Pinnacle Ceramic Liner - Gripper and Pusher LCS Total Knee System 10MM Smart TSF Ratchet Wrench Attune Revision - Taper Separator Wrench 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 GRAFT RETAINMENT - 8-16MM 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRA	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented	Unknown	Class 3	N/A	2018-12-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-12-11
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2018-12-11
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-12-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-12-11
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2025-03-31
MRA	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented	Unknown	Class 3	N/A	2018-12-11
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-12-11
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	Unknown	Class 3	N/A	2021-12-01
HXC	Wrench	Orthopedic	Class 1	888.4540	2018-12-14
OVO	Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation	Unknown	Class 3	N/A	2018-12-11
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2018-12-11
HWT	Template	Orthopedic	Class 1	888.4800	2018-12-13
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2018-12-14
JDK	Prosthesis, Hip, Cement Restrictor	General, Plastic Surgery	Class 2	878.3300	2018-12-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2016-09-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-12-11
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2018-12-11
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2018-12-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-12-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-12-11

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
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
K910547	Turnkey Intergration USA, Inc.	FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)	1991-04-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1218882. Last updated year: 2026. Please use registration number 1218882 when referencing this establishment in official correspondence.