510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230012Unknown

Ruthless Spine RJB

Ruthless LLC dba Ruthless Spine, Irwindale CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN230012 is the FDA 510(k) clearance record for Ruthless Spine RJB, a class II device, cleared for Ruthless, LLC Dba Ruthless Spine on under FDA product code QWL (Intraoperative Surgical Angle Measurement Tool). FDA's definition for product code QWL reads: "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...". FDA records list 3 510(k) clearances for Ruthless, LLC Dba Ruthless Spine, from to . As of , FDA records show no recalls naming DEN230012.

Clearance record

Decision date
Received
(148 days to decision)
Product code
QWL Intraoperative Surgical Angle Measurement Tool
Regulation
21 CFR 888.4560
Device class
Class II
Review panel
Orthopedic
Applicant
Ruthless, LLC Dba Ruthless Spine 1438 Arrow Hwy. Suite F/G, Irwindale CA
Third party review
No

Clearances, product code QWL

Trailing 12 months

FDA records hold no clearances under product code QWL in the trailing twelve months.

FDA records show no clearances under product code QWL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QWL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260