Contract manufacturerSpartronics Watertown LLC (Watertown, SD)South DakotaCardiovascularEar, nose and throatGastroenterology and urologyGeneral hospitalGeneral and plastic surgeryNeurologyPhysical medicineRadiologyClinical chemistryHematologyAnesthesiologyClass IIClass IClass III
Spartronics Watertown LLC
Contract manufacturer · Watertown, SD
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2133772 (openFDA record; or search FDA's registration database)
- FEI number
- 3000209794
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Spartronics Watertown LLC (FDA owner/operator no. 10045726)
- Registered address
- 2920 KELLY AVE, Watertown, SD 57201
- Contract listings
- 12 device listings, 24 product codes, first listed May 24, 2021
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | Contract manufacturing | Jan 30, 2025 |
| ETN | Stimulator, Nerve | Class II | Ear, nose and throat | Contract manufacturing | May 24, 2021 |
| FCG | Biopsy Needle | Class II | Gastroenterology and urology | Contract manufacturing | Jun 24, 2021 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General hospital | Contract manufacturing | Jul 30, 2026 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Jul 14, 2021 |
| GWF | Stimulator, Electrical, Evoked Response | Class II | Neurology | Contract manufacturing | May 24, 2021 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | May 24, 2021 |
| IKN | Electromyograph, Diagnostic | Class II | Physical medicine | Contract manufacturing | May 24, 2021 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Class II | Radiology | Contract manufacturing | May 24, 2021 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Jul 14, 2021 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract manufacturing | Jun 24, 2021 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Class III | Neurology | Contract manufacturing | May 21, 2026 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class II | General hospital | Contract manufacturing | Apr 3, 2023 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | Contract manufacturing | May 24, 2021 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | Class III | Neurology | Contract manufacturing | May 21, 2026 |
| NHL | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | Class III | Neurology | Contract manufacturing | May 21, 2026 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | May 24, 2021 |
| OND | Osmolality Of Tears | Class I | Clinical chemistry | Contract manufacturing | Jul 14, 2021 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Class II | Hematology | Contract manufacturing | Jul 14, 2021 |
| OWB | Interventional Fluoroscopic X-Ray System | Class II | Radiology | Contract manufacturing | May 24, 2021 |
| PDQ | Neurosurgical Nerve Locator | Class II | Ear, nose and throat | Contract manufacturing | May 24, 2021 |
| PJS | Stimulator, Electrical, Implanted, For Essential Tremor | Class III | Neurology | Contract manufacturing | May 21, 2026 |
| QRB | Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | Class III | Neurology | Contract manufacturing | May 21, 2026 |
| QTB | Nitric Oxide Generator And Delivery System | Class III | Anesthesiology | Contract manufacturing | Jul 11, 2022 |