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FDA PRODUCT CODE · CLASS II

PQCPedicle Screw Placement Guide

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3070
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
ImplantLife-sustainingGMP-exemptThird-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K253472Mighty Oak Medical · 510k2026-02-25

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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