Cleared Traditional

MediExpand TL Expandable VBR System

K190349 · Cmf Medicon Surgical, Inc. · Orthopedic

Oct 2019

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K190349 is an FDA 510(k) clearance for the MediExpand TL Expandable VBR System, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Cmf Medicon Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 24, 2019, 252 days after receiving the submission on February 14, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K190349 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2019
Decision Date	October 24, 2019
Days to Decision	252 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF