FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ruthless Spine RJB
K Number: K252615
·
Decision Sep 17, 2025
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
3
Review Days
29
Basic Information
- Device Name
- Ruthless Spine RJB
- K Number
- K252615
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.4560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ruthless, LLC Dba Ruthless Spine
- Date Received
- August 19, 2025
- Decision Date
- September 17, 2025
- Product Code
- QWL
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QWL | Intraoperative Surgical Angle Measurement Tool | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QWL), ordered by most recent decision date.
Ruthless Spine RJB
FDA 510(k)
FDA Class 2
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Ruthless Spine RJB
FDA 510(k)
FDA Class 2
·Orthopedic