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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K190349
Device Name MediExpand TL Expandable VBR System
Applicant
Cmf Medicon Surgical, Inc.
11200 St. Johns Industrial Pkwy. N. Suite 1
Jacksonville,  FL  32246
Applicant Contact Therese Davey
Correspondent
Regulatory Compliance Associates
102 Finwood Dr.
Baldwinsville,  NY  13027
Correspondent Contact David Klementowski
Regulation Number888.3060
Classification Product Code
MQP  
Date Received02/14/2019
Decision Date 10/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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