Nevro Corporation: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Nevro Corporation”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130022 | PMA | NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM | 2015-05-08 |
Recalls
openFDA lists no recalls under a recalling firm named Nevro Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Nevro Corporation is the lead sponsor of 6 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT06909292: Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1 (Recruiting, started 2025-04-03)
- NCT05777317: Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy (Active not recruiting, started 2023-04-24)
- NCT05301816: PDN Post Market, Multicenter, Prospective, Global Clinical Study (Recruiting, started 2022-07-05)
- NCT06897280: Clinical Trial of MED HF10™ Spinal Cord Stimulation for the Treatment of Chronic Pain (Active not recruiting, started 2021-11-16)
- NCT02703818: SCS for the Treatment Of Chronic Pain of the Upper Extremities (Completed, started 2016-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nevro Corporation?
FDA lists 0 510(k) clearances under the applicant name “Nevro Corporation”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Nevro Corporation?
The most frequent FDA product codes under this applicant name are LGW (Stimulator, Spinal-Cord, Totally Implanted For Pain Relief, 1).
Next steps
- See all 0 Nevro Corporation clearances with predicates and recalls
- Run predicate analysis for product code LGW, Nevro Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.