FDA Registration
Active
🇺🇸 United States
Spartronics Watertown LLC
Reg #: 2133772
·
FEI: 3000209794
·
Expires 2026
Products
23
Proprietary Names
19
Establishment Types
1
Classifications
23
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Registration Details
- Registration Name
- Spartronics Watertown LLC
- Registration Number
- 2133772
- FEI Number
- 3000209794
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2920 KELLY AVE
- City
- Watertown
- State
- SD
- ZIP
- 57201
- Country
- US
Owner / Operator
- Firm Name
- Spartronics Watertown LLC
- Operator Number
- 10045726
- Address
- 2920 Kelly Avenue, PO Box 430
- City
- Watertown
- State
- SD
- Postal Code
- 57201
- Country
- US
- Correspondent
- Evan McConnell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-07-14 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2026-05-21 |
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | Class 3 | Unknown | No | 2026-05-21 |
| Nitric Oxide Generator And Delivery System | QTB | Class 3 | Unknown | No | 2022-07-11 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2021-05-24 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2021-05-24 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-05-24 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2021-05-24 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2021-05-24 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2021-05-24 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2021-05-24 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2021-05-24 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2021-05-24 |
| Stimulator, Electrical, Implanted, For Parkinsonian Tremor | MHY | Class 3 | Unknown | No | 2026-05-21 |
| Stimulator, Electrical, Implanted, For Essential Tremor | PJS | Class 3 | Unknown | No | 2026-05-21 |
| Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | NHL | Class 3 | Unknown | No | 2026-05-21 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2021-06-24 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2021-06-24 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2021-07-14 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2025-01-30 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| Osmolality Of Tears | OND | Class 1 | Clinical Chemistry | No | 2021-07-14 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2023-04-03 |
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
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
NuVasive NVM5 System
TearLab Osmolarity System
VPS Rhythm® DLX Device
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)