Ruthless Spine RJB
FDA 510(k) clearance K252615 · decided 2025-09-17
Clearance details
- K-number
- K252615
- Device name
- Ruthless Spine RJB
- Applicant
- Ruthless, LLC Dba Ruthless Spine
- Decision
- Substantially Equivalent
- Date received
- 2025-08-19
- Decision date
- 2025-09-17
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- QWL
- Device class
- 2
- Regulation number
- 888.4560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irwindale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ruthless Spine RJB (K243375) | Ruthless, LLC Dba Ruthless Spine | 2024-11-29 |
| Ruthless Spine RJB (DEN230012) | Ruthless, LLC Dba Ruthless Spine | 2023-07-14 |
Recalls involving this device
No recalls on record reference this clearance.