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Pedicle Screw Placement Guide

Pedicle Screw Placement Guide 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.

Global Registration Data
Multi-Country Intelligence
Pedicle Screw Placement Guide
Orthopedic Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PQC

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Class 2

21 CFR 888.3070

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Orthopedic

Device Characteristics

No

No

No

Not Eligible

Definition

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.