PLR

Spinal Vertebral Body Replacement Device - Cervical

Product code
PLR
Device name
Spinal Vertebral Body Replacement Device - Cervical
Device class
Class 2
21 CFR
21 CFR 888.3060
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
3
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
19 (all years; only the last 3 years are listed here)

FDA classification definition

Vertebral body replacement in the cervical spine.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-07-15.

NumberDecision dateApplicantDevice nameSummary
K2528222026-07-15Atlas Spine, Inc.Atlas Spine HiRISE™ Expandable Cervical-p CorpectomyPDF
K2525602025-11-10Atlas Spine, Inc.Atlas Spine HiRISE™ Expandable Cervical Corpectomy S
K2324812023-10-13MiRus, LLCRIGEL™ 3DR Anterior Cervical Corpectomy SystemFDA

1 summaries are archived here for direct download.

Official FDA classification page: PLR
Classification and pathway per current FDA publications. Data from openFDA (CC0).