PLR · Class II · 21 CFR 888.3060

FDA Product Code PLR: Spinal Vertebral Body Replacement Device - Cervical

Vertebral Body Replacement In The Cervical Spine.

Leading manufacturers include K2m, Inc. and MiRus, LLC.

2
Total
2
Cleared
179d
Avg days
2022
Since

List of Spinal Vertebral Body Replacement Device - Cervical devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Oct 13, 2023
RIGEL™ 3DR Anterior Cervical Corpectomy System
K232481
MiRus, LLC
Orthopedic · 58d
Cleared Feb 24, 2022
CAPRI Corpectomy Cage System
K211320
K2m, Inc.
Orthopedic · 300d

How to use this database

This page lists all FDA 510(k) submissions for Spinal Vertebral Body Replacement Device - Cervical devices (product code PLR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →