Intraoperative Surgical Angle Measurement Tool

QWL · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.4560

Classification

FDA Product Code: QWL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.4560
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown