FDA.report

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

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Related GUDID Devices

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G492RJBPRB20Ruthless Spine Duckbill ProbeRuthless Spine2024-01-29
G492RJBPRB10Ruthless Spine Straight ProbeRuthless Spine2024-01-29
G492RJB61Ruthless Spine RJB - CaseRuthless Spine2024-01-29
G492RJB60Ruthless Spine RJBRuthless Spine2024-01-29

Other 510(k) Records For Product Code QWL

510(k)DeviceApplicantDecision date
K252615Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine2025-09-17
K243375Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine2024-11-29