FDA Product Code PQC: Pedicle 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.
Leading manufacturers include Medacta International S.A. and Mighty Oak Medical.
FDA 510(k) Cleared Pedicle Screw Placement Guide Devices (Product Code PQC)
About Product Code PQC - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PQC since 2016, with 8 receiving FDA clearance (average review time: 107 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under PQC have taken an average of 138 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.
PQC devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →