510(k) K243375

Device
Ruthless Spine RJB
Applicant
Ruthless, LLC Dba Ruthless Spine
510(k) number
K243375
Product code
QWL
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-29
Date received
2024-10-30
Regulation
888.4560
Classification name
Intraoperative Surgical Angle Measurement Tool
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Renita Howard
Address
1438 Arrow Hwy. Suite F Irwindale CA US 91706 91706

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code QWL

510(k)DeviceApplicantDecision date
K252615Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine2025-09-17
DEN230012Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine2023-07-14