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510(k) K243375

Ruthless Spine RJB by Ruthless, LLC Dba Ruthless Spine — Product Code QWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2024
Date Received
October 30, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intraoperative Surgical Angle Measurement Tool
Device Class
Class II
Regulation Number
888.4560
Review Panel
OR
Submission Type

An intraoperative surgical angle measurement tool attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy.

Other clearances by Ruthless, LLC Dba Ruthless Spine

  • K252615 — Ruthless Spine RJB (September 17, 2025)
  • DEN230012 — Ruthless Spine RJB (July 14, 2023)

Other clearances for product code QWL

  • K252615 — Ruthless Spine RJB (September 17, 2025)
  • DEN230012 — Ruthless Spine RJB (July 14, 2023)