PQCClass II

Pedicle Screw Placement Guide

21 CFR 888.3070 / Orthopedic

PQC is the FDA product code for Pedicle Screw Placement Guide, a class II device type, regulated under 21 CFR 888.3070. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 2026-02-25, and no recalls.

Classification record

Product code: PQC
Device name: Pedicle Screw Placement Guide
FDA 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.
Regulation: 21 CFR 888.3070
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 8
Ingested recalls: 0

Clearances, product code PQC

By decision year

8 clearances under product code PQC with a decision year between 2016 and 2026, 2018 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code PQC by decision year
Year	Clearances
2016	1
2018	3
2020	1
2021	1
2023	1
2026	1

Applicants with the most clearances

Product code PQC

Applicants holding the most 510(k) clearances under product code PQC
Applicant	Clearances
Mighty Oak Medical	4
Medacta International SA	3
Medacta Inernational SA	1

Companies listing this code with FDA

Companies whose registered establishments list this code