FDA Product Code NQW: Orthosis, Spine, Plate, Laminoplasty, Metal
Under FDA product code NQW, laminoplasty spinal plates are cleared for posterior cervical spine reconstruction after laminoplasty procedures.
These metal plates are attached to the laminae and lateral masses to hold the opened laminae in an elevated position after laminoplasty, maintaining the expanded spinal canal and protecting the spinal cord while enabling bone healing across the opened hinge.
NQW devices are Class II medical devices, regulated under 21 CFR 888.3050 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Vy Spine, LLC, Medtronic Sofamor Danek and Curiteva, Inc..
FDA 510(k) Cleared Orthosis, Spine, Plate, Laminoplasty, Metal Devices (Product Code NQW)
About Product Code NQW - Regulatory Context
510(k) Submission Activity
29 total 510(k) submissions under product code NQW since 2004, with 29 receiving FDA clearance (average review time: 93 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under NQW have taken an average of 29 days to reach a decision - down from 98 days historically, suggesting improved FDA processing for this classification.
NQW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →