Product code SCY

Device name

Sacroiliac Joint Guidewire Placement Device

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3040

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset