NQW · Class II · 21 CFR 888.3050

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 Curiteva, Inc., Vy Spine, LLC and Life Spine, Inc..

30
Total
30
Cleared
98d
Avg days
2004
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 104d avg (recent)

FDA 510(k) Cleared Orthosis, Spine, Plate, Laminoplasty, Metal Devices (Product Code NQW)

30 devices
1–24 of 30
Cleared May 27, 2026
AQUA Laminoplasty Systems
K252930
ZheJiang Decans Medical Devices Co., Ltd.
Orthopedic · 254d
Cleared Oct 28, 2024
Curiteva Porous PEEK Laminoplasty System
K243137
Curiteva, Inc.
Orthopedic · 28d
Cleared Oct 16, 2024
Vy Spine™ VyLam™ Laminoplasty System
K242784
Vy Spine, LLC
Orthopedic · 30d
Cleared Oct 10, 2023
Vy Spine™ VyLam™ Laminoplasty System
K232471
Vy Spine, LLC
Orthopedic · 55d
Cleared Jun 28, 2023
Curiteva Laminoplasty System
K231232
Curiteva, Inc.
Orthopedic · 61d
Cleared Dec 13, 2021
Centerpiece Plate Fixation System
K212428
Medtronic Sofamor Danek
Orthopedic · 131d
Cleared Sep 20, 2019
Hinged Laminoplasty System
K191927
Life Spine, Inc.
Orthopedic · 63d
Cleared Jul 03, 2019
NuVasive® Camber Laminoplasty System
K191169
Nu Vasive, Incorporated
Orthopedic · 63d
Cleared Oct 12, 2018
Life Spine Laminoplasty System
K181717
Life Spine, Inc.
Orthopedic · 106d
Cleared Jan 19, 2018
Choice Spine Laminoplasty™ Fixation System
K173215
Choicespine, LP
Orthopedic · 109d
Cleared Jul 14, 2017
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
K171413
Globus Medical, Inc.
Orthopedic · 60d

About Product Code NQW - Regulatory Context

510(k) Submission Activity

30 total 510(k) submissions under product code NQW since 2004, with 30 receiving FDA clearance (average review time: 98 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - NQW Product Code

FDA review times for NQW submissions have been consistent, averaging 104 days recently vs 98 days historically.

NQW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →