FDA.report

510(k) K252615

Device
Ruthless Spine RJB
Applicant
Ruthless, LLC Dba Ruthless Spine
510(k) number
K252615
Product code
QWL
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-17
Date received
2025-08-19
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

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G492RJBMPV71020Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 10 GaugeRuthless Spine2025-12-09
G492RJBMPV71010Ruthless Spine MPV7 (Jamshidi Needle) Bevel Tip, 10 GaugeRuthless Spine2025-12-09
G492RJBMPV70820Ruthless Spine MPV7 (Jamshidi Needle) Diamond Tip, 8 GaugeRuthless Spine2025-12-09
G492RJBMPV70810Ruthless Spine MPV7 (Jamshidi Needle) Bevel Tip 8 GaugeRuthless Spine2025-12-09
G492RJBFLT10Ruthless Spine Duckbill Probe, PlasticRuthless Spine2025-12-09

Other 510(k) Records For Product Code QWL

510(k)DeviceApplicantDecision date
K243375Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine2024-11-29
DEN230012Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine2023-07-14