FDA product code MRW: System, Facet Screw Spinal Device
MRW is the FDA product code for system, facet screw spinal device. It is a Unclassified device, reviewed by the Orthopedic panel. FDA has cleared 78 510(k) submissions under MRW, 24 in the last five years, from 46 different applicants. The average 510(k) review took 120 days (median 89); 120 days on average over the last three years. FDA has posted 4 recalls for MRW devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Facet Screw Spinal Device |
| Device class | Unclassified |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MRW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 77 |
| 2018 | 2 | 96 |
| 2019 | 3 | 154 |
| 2022 | 3 | 184 |
| 2023 | 3 | 182 |
| 2024 | 7 | 80 |
| 2025 | 7 | 124 |
| 2026 | 4 | 157 |
Compare with all 510(k) review times · Search every MRW clearance
Top MRW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Providence Medical Technology, Inc. | 9 | 2026-05-14 |
| SurGenTec, LLC | 6 | 2026-06-11 |
| Nuvasive, Inc. | 4 | 2010-07-15 |
| Triage Medical, Inc. | 4 | 2006-09-14 |
| Sc Medica | 3 | 2025-12-04 |
41 more applicants have MRW clearances. See the full list in Caduvo.
Most recent MRW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261209 | SurGenTec, LLC | Ion-L | 2026-06-11 | 59 |
| K253676 | Providence Medical Technology, Inc. | CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D) | 2026-05-14 | 174 |
| K253432 | Vy Spine, LLC | DiversiVy Facet Screw System | 2026-03-19 | 169 |
| K251714 | SurGenTec, LLC | Ion-C | 2026-01-16 | 227 |
| K250679 | Sc Medica | FFX Facet Fixation System | 2025-12-04 | 273 |
Recalls for MRW devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-04-27.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code MRW?
MRW is the FDA product code for system, facet screw spinal device. It is a Unclassified device, reviewed by the Orthopedic panel.
What device class is MRW?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code MRW?
Across 78 cleared submissions the average was 120 days from receipt to decision (median 89).
Which companies have the most MRW clearances?
Providence Medical Technology, Inc. (9); SurGenTec, LLC (6); Nuvasive, Inc. (4); Triage Medical, Inc. (4); Sc Medica (3).
Have MRW devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2021-04-27.
Next steps
- Run an FDA pathway report with predicate devices for product code MRW
- Run a recall and safety report across every MRW manufacturer
- Watch product code MRW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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