Cleared Traditional

MediExpand Cervical Expandable VBR System

K212126 · Cmf Medicon Surgical, Inc. · Orthopedic

Apr 2022

Decision

271d

Days

Class 2

Risk

About This 510(k) Submission

K212126 is an FDA 510(k) clearance for the MediExpand Cervical Expandable VBR System, a Spinal Vertebral Body Replacement Device - Cervical (Class II — Special Controls, product code PLR), submitted by Cmf Medicon Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on April 4, 2022, 271 days after receiving the submission on July 7, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K212126 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2021
Decision Date	April 04, 2022
Days to Decision	271 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PLR — Spinal Vertebral Body Replacement Device - Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3060
Definition	Vertebral Body Replacement In The Cervical Spine.