MediExpand Cervical Expandable VBR System

Q: What is the product code of K212126?

The FDA product code is PLR – Spinal Vertebral Body Replacement Device - Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3060.

FDA 510(k) K212126 · Cmf Medicon Surgical, Inc.

Substantially Equivalent

510(k) numberK212126

Submission

Device name: MediExpand Cervical Expandable VBR System
Applicant: Cmf Medicon Surgical, Inc.
Jacksonville, FL, US
Received: July 7, 2021
Decision date: April 4, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PLR – Spinal Vertebral Body Replacement Device - Cervical
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3060
Specialty: Orthopedic
Implant: Yes

Vertebral body replacement in the cervical spine.

Other 510(k)s with product code PLR

510(k)	Device	Applicant	Decision
K252822	Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional	Atlas Spine, Inc.	07/15/2026SE
K252560	Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional	Atlas Spine, Inc.	11/10/2025SE
K232481	RIGEL 3DR Anterior Cervical Corpectomy SystemPLR · Traditional	MiRus, LLC	10/13/2023SE
K221542	Galileo Vertebral Body Replacement DevicePLR · Special	Bright Spine	01/13/2023SE
K211320	CAPRI Corpectomy Cage SystemPLR · Traditional	K2m, Inc.	02/24/2022SE
K192145	Galileo Vertebral Body Replacement DevicePLR · Traditional	Bright Spine	04/21/2020SE
K193412	NEXXT MATRIXX SystemPLR · Traditional	Nexxt Spine, LLC	02/24/2020SE
K190284	Bengal Stackable Cage SystemPLR · Traditional	Medos International SARL	12/20/2019SE
K190426	ALTA Anterior Cervical Corpectomy SystemPLR · Traditional	Astura Medical, LLC	10/24/2019SE
K191778	Omnia Medical VBRPLR · Special	Omnia Medical, LLC	08/28/2019SE

More from Omnia Medical, LLC

510(k)	Device	Decision
K241253	Medicon Epiplating SystemFZE · Traditional	12/12/2024SE
K242764	MediRod Pedicle Screw SystemNKB · Traditional	11/13/2024SE
K190349	MediExpand TL Expandable VBR SystemMQP · Traditional	10/24/2019SE

Questions and answers

When was MediExpand Cervical Expandable VBR System cleared by the FDA?

MediExpand Cervical Expandable VBR System (K212126) received a 510(k) decision of Substantially Equivalent on April 4, 2022, 271 days after the submission was received.

What is the product code of K212126?

The FDA product code is PLR – Spinal Vertebral Body Replacement Device - Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3060.