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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 - Cervical
510(k) Number K212126
Device Name MediExpand Cervical Expandable VBR System
Applicant
Cmf Medicon Surgical, Inc.
11200 St. Johns Industrial Pkwy. N. Suite 1
Jacksonville,  FL  32246
Applicant Contact Matthias Alber
Correspondent
Cmf Medicon Surgical, Inc.
11200 St. Johns Industrial Pkwy. N. Suite 1
Jacksonville,  FL  32246
Correspondent Contact Matthias Alber
Regulation Number888.3060
Classification Product Code
PLR  
Date Received07/07/2021
Decision Date 04/04/2022
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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