SPR Therapeutics, Inc
Cleveland, OH, US
SPR THERAPEUTICS, INC appears in FDA device records in Cleveland, OH. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for SPR Therapeutics, Inc between 2016 and 2026. The busiest year on record is 2021, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2021 | 2 |
| 2023 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240974 | SPRINT PNS System | SCN | Substantially Equivalent | |
| K223306 | SPRINT Peripheral Nerve Stimulation (PNS) System | NHI | Substantially Equivalent | |
| K211801 | SPRINT PNS System | NHI | Substantially Equivalent | |
| K202660 | SPRINT PNS System | NHI | Substantially Equivalent | |
| K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit | NHI | Substantially Equivalent | |
| K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit | NHI | Substantially Equivalent | |
| K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs | NHI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011035812 | 3011035812 | SPR THERAPEUTICS, INC | 22901 MILLCREEK BLVD STE 500, Cleveland, OH 44122 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain