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Sacroiliac Joint Guidewire Placement Device

FDA product code SCY · 1 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3040
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-09-26 – 2024-09-26

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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