Ruthless, LLC Dba Ruthless Spine: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Ruthless, LLC Dba Ruthless Spine” (first 2024, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 30 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 30 |
| 2025 | 1 | 29 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ruthless, LLC Dba Ruthless Spine took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 30 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QWL | Intraoperative Surgical Angle Measurement Tool | 3 | 2 |
Review panels
- Orthopedic (3)
Most recent Ruthless, LLC Dba Ruthless Spine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252615 | Ruthless Spine RJB | QWL | 2025-09-17 | 29 |
| K243375 | Ruthless Spine RJB | QWL | 2024-11-29 | 30 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230012 | De Novo | Intraoperative Surgical Angle Measurement Tool | 2023-07-14 |
Recalls
openFDA lists no recalls under a recalling firm named Ruthless, LLC Dba Ruthless Spine.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ruthless, LLC Dba Ruthless Spine?
FDA lists 2 510(k) clearances under the applicant name “Ruthless, LLC Dba Ruthless Spine” (first 2024, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ruthless, LLC Dba Ruthless Spine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ruthless, LLC Dba Ruthless Spine is 30 days.
Which FDA product codes appear under Ruthless, LLC Dba Ruthless Spine?
The most frequent FDA product codes under this applicant name are QWL (Intraoperative Surgical Angle Measurement Tool, 3).
Next steps
- See all 2 Ruthless, LLC Dba Ruthless Spine clearances with predicates and recalls
- Run predicate analysis for product code QWL, Ruthless, LLC Dba Ruthless Spine'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.