PLRClass II

Spinal Vertebral Body Replacement Device - Cervical

21 CFR 888.3060 / Orthopedic

PLR is the FDA product code for Spinal Vertebral Body Replacement Device - Cervical, a class II device type, regulated under 21 CFR 888.3060. FDA's definition for this code reads: "Vertebral body replacement in the cervical spine". As of 2026-09-10, FDA records hold 19 510(k) clearances under this code, the most recent dated 2026-07-15, and no recalls.

Classification record

Product code: PLR
Device name: Spinal Vertebral Body Replacement Device - Cervical
FDA definition: Vertebral body replacement in the cervical spine.
Regulation: 21 CFR 888.3060
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 19
Ingested recalls: 0

Clearances, product code PLR

By decision year

19 clearances under product code PLR with a decision year between 2015 and 2026, 2019 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code PLR by decision year
Year	Clearances
2015	1
2016	1
2017	1
2018	3
2019	5
2020	2
2022	2
2023	2
2025	1
2026	1

Applicants with the most clearances

Product code PLR

Applicants holding the most 510(k) clearances under product code PLR
Applicant	Clearances
Atlas Spine, Inc.	2
Bright Spine	2
Nu Vasive, Incorporated	2
Zavation Medical Products, LLC	2
Aesculap Implants Systems, LLC	1
Astura Medical	1
Cardinal Spine, LLC	1
CMF Medicon Surgical Inc	1
Coligne AG	1
K2M, Inc	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 62 companies shown, in name order