Sacroiliac Joint Guidewire Placement Device

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

Classification

FDA Product Code: SCY
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 joint guidewire placement device is intended to be used to assist in locating the sacroiliac joint and placing a guidewire in the joint as part of sacroiliac joint fusion surgeries to place implants into the sacroiliac joint.

Market data

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

Source

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