

# MRW · System, Facet Screw Spinal Device

_ ·  · Class U_

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

## Overview

- **Product Code:** MRW
- **Device Name:** System, Facet Screw Spinal Device
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Recent Cleared Devices (20 of 77)

Showing 20 most recent of 77 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253676](/device/K253676.md) | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) | Providence Medical Technology, Inc. | May 14, 2026 | SESE |
| [K253432](/device/K253432.md) | DiversiVy™ Facet Screw System | Vy Spine, LLC | Mar 19, 2026 | SESE |
| [K251714](/device/K251714.md) | Ion-C | SurGenTec, LLC | Jan 16, 2026 | SESE |
| [K250679](/device/K250679.md) | FFX Facet Fixation System | Sc Medica | Dec 4, 2025 | SESE |
| [K253190](/device/K253190.md) | CORUS-LX Implant | Providence Medical Technology, Inc. | Nov 20, 2025 | SESE |
| [K252153](/device/K252153.md) | FFX Facet Fixation System | Sc Medica | Oct 16, 2025 | SESE |
| [K251885](/device/K251885.md) | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. | Jul 10, 2025 | SESE |
| [K250920](/device/K250920.md) | Arthrex Spine Compression FT Screw | Arthrex, Inc. | May 22, 2025 | SESE |
| [K242527](/device/K242527.md) | The Karma® Fixation System | Spinal Elements, Inc. | May 21, 2025 | SESE |
| [K243865](/device/K243865.md) | AERO MIS Facet Fusion System | Aurora Spine | Mar 24, 2025 | SESE |
| [K243265](/device/K243265.md) | Ion 3D | SurGenTec, LLC | Dec 4, 2024 | SESE |
| [K242650](/device/K242650.md) | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | Sep 20, 2024 | SESE |
| [K241035](/device/K241035.md) | PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. | Jun 25, 2024 | SESE |
| [K241416](/device/K241416.md) | Ion 3D | SurGenTec, LLC | Jun 17, 2024 | SESE |
| [K232468](/device/K232468.md) | SC Medica FFX | Sc Medica | May 9, 2024 | SESE |
| [K240085](/device/K240085.md) | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | Apr 18, 2024 | SESE |
| [K240086](/device/K240086.md) | Ion 3D | SurGenTec, LLC | Feb 8, 2024 | SESE |
| [K230840](/device/K230840.md) | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | Dec 19, 2023 | SESE |
| [K232877](/device/K232877.md) | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System | K&J Consulting Corporation | Dec 13, 2023 | SESE |
| [K230297](/device/K230297.md) | PMT Expandable Cage (PMT EXP) | Providence Medical Technology, Inc. | Aug 11, 2023 | SESE |

## Top Applicants

- Providence Medical Technology, Inc. — 9 clearances
- SurGenTec, LLC — 5 clearances
- Nuvasive, Inc. — 4 clearances
- Triage Medical, Inc. — 4 clearances
- Globus Medical, Inc. — 3 clearances

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

**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
