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Pedicle Screw Placement Guide

FDA product code PQC · 8 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3070
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-10-28 – 2026-02-25

A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.

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