Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2133772

FEI Number

3000209794

Entity Name

Spartronics Watertown LLC

City/State/Country

Watertown, SD, US

Establishment Address

2920 KELLY AVE, Watertown, SD 57201, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Spartronics Watertown LLC (Owner Number: 10045726)

Owner / Operator Contact Address

2920 Kelly Avenue, PO Box 430, Watertown, SD 57201, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CoolSeal Generator Charger Kit, Lumbar 36000 Charger 16000 SCS Charging System 36700 LungFit® PH LungFit® PH Verification Kit (90015) LungFit® PH Bagging Kit (90005) LungFit® PH NO2 Filter (90008) LungFit® PH NDM Assembly (90014) NuVasive® Pulse System Liberta RC Charger Kit 66000 DBS Charging System 66700 Charger 16000 ONCONTROL BONE MARROW BIOPSY SYSTEM Angel® Concentrated Platelet Rich Plasma (cPRP) System EnSite X EP System ECG Output Module EnSite X EP System Catheter Input Module

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-07-14
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2026-05-21
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2026-05-21
QTB	Nitric Oxide Generator And Delivery System	Unknown	Class 3	N/A	2022-07-11
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2021-05-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-05-24
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-05-24
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-05-24
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2021-05-24
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2021-05-24
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-05-24
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2021-05-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-05-24
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Unknown	Class 3	N/A	2026-05-21
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Unknown	Class 3	N/A	2026-05-21
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Unknown	Class 3	N/A	2026-05-21
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-06-24
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2021-06-24
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2021-07-14
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-01-30

Official Correspondent

Evan McConnell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spartronics Watertown LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2133772. Last updated year: 2026. Please use registration number 2133772 when referencing this establishment in official correspondence.