FDA Product Code KWQ: Appliance, Fixation, Spinal Intervertebral Body
FDA product code KWQ covers spinal intervertebral body fixation appliances.
These devices are implanted between adjacent vertebral bodies to restore disc height, maintain spinal alignment, and facilitate interbody fusion. They include standalone interbody cages and spacers used in anterior, posterior, lateral, and oblique lumbar fusion approaches.
KWQ devices are Class II medical devices, regulated under 21 CFR 888.3060 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Nuvasive, Inc., Globus Medical, Inc. and K2m, Inc..
667
Total
667
Cleared
111d
Avg days
1979
Since
Declining activity -
19 submissions in the last 2 years
vs 37 in the prior period
Review times improving: avg
87d
recently vs 111d historically
FDA 510(k) Cleared Appliance, Fixation, Spinal Intervertebral Body Devices (Product Code KWQ)
667 devices
Cleared
May 14, 2026
ARIES Anterior Cervical Plate Systems
ZheJiang Decans Medical Devices Co., Ltd.
Orthopedic
254d
Cleared
May 06, 2026
CastleLoc-P Anterior Cervical Plate System
L & K Biomed Co., Ltd.
Orthopedic
33d
Cleared
Apr 22, 2026
corra™ cervical plating system
Carlsmed, Inc.
Orthopedic
62d
Cleared
Mar 27, 2026
VyPlate™ Anterior Cervical Plate System
Vy Spine, LLC
Orthopedic
23d
Cleared
Mar 04, 2026
ANTERIS Thoracolumbar Plate System
SpineCraft
Orthopedic
58d
Cleared
Mar 03, 2026
PathLoc Lumbar Plate System
L & K Biomed Co., Ltd.
Orthopedic
252d
Cleared
Feb 26, 2026
Aster
Osteonic Co., Ltd.
Orthopedic
65d
Cleared
Feb 12, 2026
Lumbar Spine Truss System - Plating Solution (LSTS-PS)
4Web, Inc.
Orthopedic
139d
Cleared
Dec 22, 2025
aprevo® cervical plating system
Carlsmed, Inc.
Orthopedic
126d
Cleared
Aug 28, 2025
Proximity Anterior Cervical Plate System
Alphatec Spine, Inc.
Orthopedic
63d
Cleared
Jul 11, 2025
Resolve Anterior Cervical Plate System
Pioneer Surgical Technology, Inc.
Orthopedic
64d
Cleared
May 23, 2025
Frida™ Anterior Cervical Plate System
Spineup, Inc.
Orthopedic
98d
Cleared
May 20, 2025
X-PAC® N-GAGE™ Lumbar Plate System
Expanding Innovations, Inc.
Orthopedic
81d
Cleared
Apr 10, 2025
Skyway Anterior Cervical Plate System
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic
50d
Cleared
Jan 14, 2025
Elegance® Anterior Cervical plate
Clariance
Orthopedic
26d
Cleared
Dec 11, 2024
Cervical Plating System
Life Spine, Inc.
Orthopedic
42d
Cleared
Nov 07, 2024
OZARK Cervical Plate System
Stryker Spine
Orthopedic
90d
Cleared
Nov 05, 2024
Skyway Anterior Cervical Plate System
Kyocera Medical Technologies, Inc.
Orthopedic
39d
Cleared
Jul 24, 2024
FlexWing Anterior Cervical Plate System
Jeil Medical Corporation
Orthopedic
450d
Cleared
May 24, 2024
Wolff's Law Anterior Cervical Plate System
Spinal Simplicity, LLC
Orthopedic
84d
Cleared
May 17, 2024
icotec Anterior Cervical Plate System
Icotec AG
Orthopedic
234d
Cleared
May 17, 2024
ARENAL Anterior Cervical Plate System
Effortmed, LLC
Orthopedic
42d
Cleared
May 17, 2024
MiRus MoRe Lumbar Plating System
MiRus, LLC
Orthopedic
21d
Cleared
Apr 17, 2024
MSFX Mikron Cervical Anterior Plate System
Mikron Makina Sanayi VE Ticaret Ltd. Sti.
Orthopedic
57d
About Product Code KWQ - Regulatory Context
510(k) Submission Activity
667 total 510(k) submissions under product code KWQ since 1979, with 667 receiving FDA clearance (average review time: 111 days).
Submission volume has declined in recent years - 19 submissions in the last 24 months compared to 37 in the prior period.
FDA 510(k) Review Time - KWQ Product Code
Recent submissions under KWQ have taken an average of 87 days to reach a decision - down from 111 days historically, suggesting improved FDA processing for this classification.
KWQ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →