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Sacroiliac Screw Placement Guide

FDA product code QSR · 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
2022-05-24 – 2022-05-24

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.

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