Sacroiliac Screw Placement Guide

QSR · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3040

Classification

FDA Product Code: QSR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3040
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A sacroiliac screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of sacroiliac screws across the sacroiliac joint. The device utilizes anatomical landmarks that are identifiable on pre-operative imaging scans.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 5

Source

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