FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Ruthless Spine RJB
K Number: DEN230012
·
Decision Jul 14, 2023
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
3
Review Days
148
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Basic Information
- Device Name
- Ruthless Spine RJB
- K Number
- DEN230012
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 888.4560
- Medical Specialty
- Orthopedic
- Decision
- Unknown
- Applicant
- Ruthless, LLC Dba Ruthless Spine
- Date Received
- February 16, 2023
- Decision Date
- July 14, 2023
- 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