510(k) DEN230012
- Device
- Ruthless Spine RJB
- Applicant
- Ruthless, LLC Dba Ruthless Spine
- 510(k) number
- DEN230012
- Product code
- QWL
- Decision
- Unknown (DENG)
- Decision date
- 2023-07-14
- Date received
- 2023-02-16
- Regulation
- 888.4560
- Classification name
- Intraoperative Surgical Angle Measurement Tool
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Renita Howard
- Address
- 1438 Arrow Hwy. Suite F/G Irwindale CA US 91706 91706
FDA Registration Numbers#
- 2028523
- 3007441485
- 3030150698
Source Documents#
510(k) summary PDF not indicated by FDA