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/submissions/OR/subpart-d%E2%80%94prosthetic-devices/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 663) Showing 20 most recent of 663 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260697](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K260697.md) | VyPlate™ Anterior Cervical Plate System | Vy Spine, LLC | Mar 27, 2026 | SESE | | [K260015](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K260015.md) | ANTERIS Thoracolumbar Plate System | SpineCraft | Mar 4, 2026 | SESE | | [K251940](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K251940.md) | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | Mar 3, 2026 | SESE | | [K254182](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K254182.md) | Aster | Osteonic Co., Ltd. | Feb 26, 2026 | SESE | | [K253201](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K253201.md) | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | Feb 12, 2026 | SESE | | [K252611](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K252611.md) | aprevo® cervical plating system | Carlsmed, Inc. | Dec 22, 2025 | SESE | | [K251965](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K251965.md) | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | Aug 28, 2025 | SESE | | [K251436](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K251436.md) | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | Jul 11, 2025 | SESE | | [K250446](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K250446.md) | Frida™ Anterior Cervical Plate System | Spineup, Inc. | May 23, 2025 | SESE | | [K250602](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K250602.md) | X-PAC® N-GAGE™ Lumbar Plate System | Expanding Innovations, Inc. | May 20, 2025 | SESE | | [K250486](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K250486.md) | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | Apr 10, 2025 | SESE | | [K243904](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K243904.md) | Elegance® Anterior Cervical plate | Clariance | Jan 14, 2025 | SESE | | [K243369](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K243369.md) | Cervical Plating System | Life Spine, Inc. | Dec 11, 2024 | SESE | | [K242361](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K243015.md) | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | Nov 5, 2024 | SESE | | [K231251](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K231251.md) | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | Jul 24, 2024 | SESE | | [K240592](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K240592.md) | Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC | May 24, 2024 | SESE | | [K241175](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K241175.md) | MiRus MoRe Lumbar Plating System | MiRus, LLC | May 17, 2024 | SESE | | [K240935](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K240935.md) | ARENAL Anterior Cervical Plate System | Effortmed, LLC | May 17, 2024 | SESE | | [K233215](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K233215.md) | icotec Anterior Cervical Plate System | Icotec AG | May 17, 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com