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 Nu Vasive, Incorporated, Zavation Medical Products, LLC and Bright Spine.

19
Total
19
Cleared
178d
Avg days
2015
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 202d recently vs 175d historically

FDA 510(k) Cleared Spinal Vertebral Body Replacement Device - Cervical Devices (Product Code PLR)

19 devices
1–19 of 19
Cleared Nov 10, 2025
Atlas Spine HiRISE™ Expandable Cervical Corpectomy System
K252560
Atlas Spine, Inc.
Orthopedic · 89d
Cleared Oct 13, 2023
RIGEL™ 3DR Anterior Cervical Corpectomy System
K232481
MiRus, LLC
Orthopedic · 58d
Cleared Jan 13, 2023
Galileo Vertebral Body Replacement Device
K221542
Bright Spine
Orthopedic · 231d
Cleared Apr 04, 2022
MediExpand Cervical Expandable VBR System
K212126
Cmf Medicon Surgical, Inc.
Orthopedic · 271d
Cleared Feb 24, 2022
CAPRI Corpectomy Cage System
K211320
K2m, Inc.
Orthopedic · 300d
Cleared Apr 21, 2020
Galileo Vertebral Body Replacement Device
K192145
Bright Spine
Orthopedic · 257d
Cleared Feb 24, 2020
NEXXT MATRIXX System
K193412
Nexxt Spine, LLC
Orthopedic · 77d
Cleared Dec 20, 2019
Bengal Stackable Cage System
K190284
Medos International SARL
Orthopedic · 312d
Cleared Oct 24, 2019
ALTA Anterior Cervical Corpectomy System
K190426
Astura Medical, LLC
Orthopedic · 244d
Cleared Aug 28, 2019
Omnia Medical VBR
K191778
Omnia Medical, LLC
Orthopedic · 57d
Cleared Aug 06, 2019
Normandy VBR System
K191423
Zavation Medical Products, LLC
Orthopedic · 69d
Cleared Jan 10, 2019
VLIFT-s Vertebral Body Replacement System
K183071
Stryker Spine
Orthopedic · 66d
Cleared Nov 20, 2018
NuVasive Monolith Cervical Corpectomy System
K180550
Nu Vasive, Incorporated
Orthopedic · 264d
Cleared Sep 06, 2018
Trabis
K173893
Coligne AG
Orthopedic · 259d
Cleared Jul 13, 2018
Normandy VBR System
K180673
Zavation Medical Products, LLC
Orthopedic · 121d
Cleared Sep 25, 2015
NuVasive X-CORE Mini Cervical Expandable VBR System
K151651
Nu Vasive, Incorporated
Orthopedic · 99d

About Product Code PLR - Regulatory Context

510(k) Submission Activity

19 total 510(k) submissions under product code PLR since 2015, with 19 receiving FDA clearance (average review time: 178 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - PLR Product Code

Recent submissions under PLR have taken an average of 202 days to reach a decision - up from 175 days historically. Manufacturers should account for longer review timelines in current project planning.

PLR devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →