Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3060](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3060) → KWQ — Appliance, Fixation, Spinal Intervertebral Body

# KWQ · Appliance, Fixation, Spinal Intervertebral Body

_Orthopedic · 21 CFR 888.3060 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/KWQ

## Overview

- **Product Code:** KWQ
- **Device Name:** Appliance, Fixation, Spinal Intervertebral Body
- **Regulation:** [21 CFR 888.3060](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3060)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **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 666)

Showing 20 most recent of 666 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252776](/device/K252776.md) | ARIES Anterior Cervical Plate Systems | ZheJiang Decans Medical Devices Co., Ltd. | May 14, 2026 | SESE |
| [K261112](/device/K261112.md) | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | May 6, 2026 | SESE |
| [K260570](/device/K260570.md) | corra™ cervical plating system | Carlsmed, Inc. | Apr 22, 2026 | SESE |
| [K260697](/device/K260697.md) | VyPlate™ Anterior Cervical Plate System | Vy Spine, LLC | Mar 27, 2026 | SESE |
| [K260015](/device/K260015.md) | ANTERIS Thoracolumbar Plate System | SpineCraft | Mar 4, 2026 | SESE |
| [K251940](/device/K251940.md) | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | Mar 3, 2026 | SESE |
| [K254182](/device/K254182.md) | Aster | Osteonic Co., Ltd. | Feb 26, 2026 | SESE |
| [K253201](/device/K253201.md) | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | Feb 12, 2026 | SESE |
| [K252611](/device/K252611.md) | aprevo® cervical plating system | Carlsmed, Inc. | Dec 22, 2025 | SESE |
| [K251965](/device/K251965.md) | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | Aug 28, 2025 | SESE |
| [K251436](/device/K251436.md) | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | Jul 11, 2025 | SESE |
| [K250446](/device/K250446.md) | Frida™ Anterior Cervical Plate System | Spineup, Inc. | May 23, 2025 | SESE |
| [K250602](/device/K250602.md) | X-PAC® N-GAGE™ Lumbar Plate System | Expanding Innovations, Inc. | May 20, 2025 | SESE |
| [K250486](/device/K250486.md) | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | Apr 10, 2025 | SESE |
| [K243904](/device/K243904.md) | Elegance® Anterior Cervical plate | Clariance | Jan 14, 2025 | SESE |
| [K243369](/device/K243369.md) | Cervical Plating System | Life Spine, Inc. | Dec 11, 2024 | SESE |
| [K242361](/device/K242361.md) | 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](/device/K243015.md) | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | Nov 5, 2024 | SESE |
| [K231251](/device/K231251.md) | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | Jul 24, 2024 | SESE |
| [K240592](/device/K240592.md) | Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC | May 24, 2024 | SESE |

## Top Applicants

- Nuvasive, Inc. — 21 clearances
- Globus Medical, Inc. — 15 clearances
- K2m, Inc. — 15 clearances
- Blackstone Medical, Inc. — 13 clearances
- Medtronic Sofamor Danek — 13 clearances

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**Source:** [https://fda.innolitics.com/productcode/KWQ](https://fda.innolitics.com/productcode/KWQ)

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**Cite:** Innolitics at https://innolitics.com