FDA product code PLR: Spinal Vertebral Body Replacement Device - Cervical
PLR is the FDA product code for spinal vertebral body replacement device - cervical. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel. FDA has cleared 19 510(k) submissions under PLR, 6 in the last five years, from 15 different applicants. The average 510(k) review took 178 days (median 155); 202 days on average over the last three years.
Definition
Vertebral body replacement in the cervical spine.
Classification
| Field | Value |
|---|---|
| Device name | Spinal Vertebral Body Replacement Device - Cervical |
| Device class | Class II |
| Regulation | 21 CFR 888.3060 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PLR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 138 |
| 2018 | 3 | 215 |
| 2019 | 5 | 150 |
| 2020 | 2 | 167 |
| 2022 | 2 | 286 |
| 2023 | 2 | 144 |
| 2025 | 1 | 89 |
| 2026 | 1 | 314 |
Compare with all 510(k) review times · Search every PLR clearance
Top PLR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Atlas Spine, Inc. | 2 | 2026-07-15 |
| Bright Spine | 2 | 2023-01-13 |
| Zavation Medical Products, LLC | 2 | 2019-08-06 |
| Nu Vasive, Incorporated | 2 | 2018-11-20 |
| MiRus, LLC | 1 | 2023-10-13 |
10 more applicants have PLR clearances. See the full list in Caduvo.
Most recent PLR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252822 | Atlas Spine, Inc. | Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant | 2026-07-15 | 314 |
| K252560 | Atlas Spine, Inc. | Atlas Spine HiRISE Expandable Cervical Corpectomy System | 2025-11-10 | 89 |
| K232481 | MiRus, LLC | RIGEL 3DR Anterior Cervical Corpectomy System | 2023-10-13 | 58 |
| K221542 | Bright Spine | Galileo Vertebral Body Replacement Device | 2023-01-13 | 231 |
| K212126 | Cmf Medicon Surgical, Inc. | MediExpand Cervical Expandable VBR System | 2022-04-04 | 271 |
Recalls for PLR devices
openFDA lists no recalls for product code PLR.
Frequently asked questions
What is FDA product code PLR?
PLR is the FDA product code for spinal vertebral body replacement device - cervical. It is a Class II device, regulated under 21 CFR 888.3060 and reviewed by the Orthopedic panel.
What device class is PLR?
Class II, regulation 21 CFR 888.3060. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLR?
Across 19 cleared submissions the average was 178 days from receipt to decision (median 155).
Which companies have the most PLR clearances?
Atlas Spine, Inc. (2); Bright Spine (2); Zavation Medical Products, LLC (2); Nu Vasive, Incorporated (2); MiRus, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PLR
- Run a recall and safety report across every PLR manufacturer
- Watch product code PLR 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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