FDA product code SCY

Sacroiliac Joint Guidewire Placement Device

Orthopedic·Class 2·21 CFR 888.3040
US regulatory classifications
US Product Code (FDA)
SCY
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3040
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Sacroiliac Joint Guidewire Placement Device is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.