Data / Medical devices / United States / SPR Therapeutics, Inc
SPR Therapeutics, Inc: FDA-registered device maker in Cleveland, OH, United States, 2 510(k) clearances
SPR Therapeutics, Inc is registered with the FDA (registration 3011035812) in Cleveland, OH, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 14, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011035812
- Address
- 22901 Millcreek BLVD Ste 500, Cleveland, OH, United States, 44122
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- August 5, 2026
- Registered through
- 2026
- Brand names listed
- SPRINT Peripheral Nerve Stimulation (PNS) System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | NHI | 2 | Manufacturer | accessdata.fda.gov |
| Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief | SCN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 14, 2026 | K240974 | SPRINT PNS System | SCN | Substantially Equivalent | Spr Therapeutics, Inc. | accessdata.fda.gov |
| January 25, 2023 | K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | NHI | Substantially Equivalent | Spr Therapeutics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
- All makers of Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief
Updated April 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.