FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ruthless Spine RJB
K Number: K243375
·
Decision Nov 29, 2024
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
3
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Ruthless Spine RJB
- K Number
- K243375
- 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
- October 30, 2024
- Decision Date
- November 29, 2024
- 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
·Orthopedic
Ruthless Spine RJB
FDA 510(k)
FDA Class 2
·Orthopedic