meddevicedb.com FDA Device Reference

Ruthless Spine RJB

DEN230012 Class II Direct
Decision Date
2023-07-14
Sponsor / Applicant
Ruthless, LLC Dba Ruthless Spine

Technical Specification

510(k) Submission ID DEN230012
Product Code QWL
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.4560
Decision Date 2023-07-14
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Ruthless Spine RJB received FDA 510(k) clearance under submission number DEN230012, sponsored by Ruthless, LLC Dba Ruthless Spine. The device was reviewed via the Direct premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-07-14.

Classification & Regulation

This clearance is catalogued under FDA product code QWL and 21 CFR 888.4560, within the Orthopedic review panel as a Class II device.