KWQ · Appliance, Fixation, Spinal Intervertebral Body
Orthopedic · 21 CFR 888.3060 · Class 2
Overview
| Product Code | KWQ |
|---|---|
| Device Name | Appliance, Fixation, Spinal Intervertebral Body |
| Regulation | 21 CFR 888.3060 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 663)
Showing 20 most recent of 663 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260697 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | Mar 27, 2026 | SESE |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | Mar 4, 2026 | SESE |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | Mar 3, 2026 | SESE |
| K254182 | Aster | Osteonic Co., Ltd. | Feb 26, 2026 | SESE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | Feb 12, 2026 | SESE |
| K252611 | aprevo® cervical plating system | Carlsmed, Inc. | Dec 22, 2025 | SESE |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | Aug 28, 2025 | SESE |
| K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | Jul 11, 2025 | SESE |
| K250446 | Frida Anterior Cervical Plate System | Spineup, Inc. | May 23, 2025 | SESE |
| K250602 | X-PAC® N-GAGE Lumbar Plate System | Expanding Innovations, Inc. | May 20, 2025 | SESE |
| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | Apr 10, 2025 | SESE |
| K243904 | Elegance® Anterior Cervical plate | Clariance | Jan 14, 2025 | SESE |
| K243369 | Cervical Plating System | Life Spine, Inc. | Dec 11, 2024 | SESE |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI | Stryker Spine | Nov 7, 2024 | SESE |
| K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | Nov 5, 2024 | SESE |
| K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | Jul 24, 2024 | SESE |
| K240592 | Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC | May 24, 2024 | SESE |
| K241175 | MiRus MoRe Lumbar Plating System | MiRus, LLC | May 17, 2024 | SESE |
| K240935 | ARENAL Anterior Cervical Plate System | Effortmed, LLC | May 17, 2024 | SESE |
| K233215 | icotec Anterior Cervical Plate System | Icotec AG | May 17, 2024 | SESE |
Top Applicants
- Nuvasive, Inc. — 21 clearances
- K2m, Inc. — 15 clearances
- Globus Medical, Inc. — 15 clearances
- Medtronic Sofamor Danek — 13 clearances
- Blackstone Medical, Inc. — 13 clearances
