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

Intraoperative Surgical Angle Measurement Tool

21 CFR 888.4560 / Orthopedic
FDA source (opens on fda.gov)

QWL is the FDA product code for Intraoperative Surgical Angle Measurement Tool, a class II device type, regulated under 21 CFR 888.4560. FDA's definition for this code 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 to patient anatomy". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QWL
Device name
Intraoperative Surgical Angle Measurement Tool
FDA definition
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.
Regulation
21 CFR 888.4560
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QWL

By decision year
3 clearances under product code QWL with a decision year between 2023 and 2025, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QWL by decision year
YearClearances
20231
20241
20251

Applicants with the most clearances

Product code QWL
Applicants holding the most 510(k) clearances under product code QWL
ApplicantClearances
Ruthless LLC dba Ruthless Spine3

Companies listing this code with FDA

Companies whose registered establishments list this code