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 Globus Medical, Inc., Curiteva, Inc. and Vy Spine, LLC.
30
Total
30
Cleared
98d
Avg days
2004
Since
Declining activity -
1 submissions in the last 2 years
vs 4 in the prior period
Review times increasing: avg
254d
recently vs 93d historically
FDA 510(k) Cleared Orthosis, Spine, Plate, Laminoplasty, Metal Devices (Product Code NQW)
30 devices
Cleared
May 27, 2026
AQUA Laminoplasty Systems
ZheJiang Decans Medical Devices Co., Ltd.
Orthopedic
254d
Cleared
Oct 28, 2024
Curiteva Porous PEEK Laminoplasty System
Curiteva, Inc.
Orthopedic
28d
Cleared
Oct 16, 2024
Vy Spine™ VyLam™ Laminoplasty System
Vy Spine, LLC
Orthopedic
30d
Cleared
Oct 10, 2023
Vy Spine™ VyLam™ Laminoplasty System
Vy Spine, LLC
Orthopedic
55d
Cleared
Jun 28, 2023
Curiteva Laminoplasty System
Curiteva, Inc.
Orthopedic
61d
Cleared
Dec 13, 2021
Centerpiece Plate Fixation System
Medtronic Sofamor Danek
Orthopedic
131d
Cleared
Sep 20, 2019
Hinged Laminoplasty System
Life Spine, Inc.
Orthopedic
63d
Cleared
Jul 03, 2019
NuVasive® Camber Laminoplasty System
Nu Vasive, Incorporated
Orthopedic
63d
Cleared
Oct 12, 2018
Life Spine Laminoplasty System
Life Spine, Inc.
Orthopedic
106d
Cleared
Jan 19, 2018
Choice Spine Laminoplasty™ Fixation System
Choicespine, LP
Orthopedic
109d
Cleared
Jul 14, 2017
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
Globus Medical, Inc.
Orthopedic
60d
Cleared
Mar 15, 2016
Xspan Laminoplasty Fixation System
X-Spine Systems, Inc.
Orthopedic
56d
Cleared
Jan 21, 2016
Release Laminoplasty Fixation System
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Orthopedic
24d
Cleared
Mar 23, 2015
Integra Laminoplasty System
Seaspine, Inc.
Orthopedic
28d
Cleared
Nov 26, 2013
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
Spinefrontier, Inc.
Orthopedic
84d
Cleared
May 09, 2013
INTEGRA LAMINOPLASTY SYSTEM
Seaspine, Inc.
Orthopedic
44d
Cleared
Feb 07, 2013
SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
Spectrum Spine, LLC
Orthopedic
146d
Cleared
Oct 31, 2012
CANOPY LAMINOPLASTY FIXATION SYSTEM
Globus Medical, Inc.
Orthopedic
140d
Cleared
Aug 29, 2012
NEURO VENTION LAMINPLASTY PLATING SYSTEM
Neurovention, LLC
Orthopedic
124d
Cleared
Apr 16, 2012
ESCALATE LAMINOPLASTY SYSTEM
Stryker Spine
Orthopedic
115d
Cleared
Jan 26, 2012
PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
Pioneer Surgical Technology, Inc.
Orthopedic
86d
Cleared
Dec 02, 2010
LAMINOPLASY PLATING SYSTEM
Aesculap Implant Systems, Inc.
Orthopedic
27d
Cleared
Jul 20, 2010
GALLERY LAMINOPLASTY FIXATION SYSTEM
Biomet Spine (Aka Ebi, LLC)
Orthopedic
120d
Cleared
Jan 07, 2010
MOUNTAINEER LAMINOPLASTY SYSTEM
Depuy Spine, Inc.
Orthopedic
189d
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 declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA 510(k) Review Time - NQW Product Code
Recent submissions under NQW have taken an average of 254 days to reach a decision - up from 93 days historically. Manufacturers should account for longer review timelines in current project planning.
NQW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →