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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K201136
Device Name Cure™ Lumbar Plate System
Applicant
Meditech Spine, LLC
1447 Peachtree St. NE Suite 440
Atlanta,  GA  30309
Applicant Contact Bruce Dunaway
Correspondent
Meditech Spine, LLC
1447 Peachtree St. NE Suite 440
Atlanta,  GA  30309
Correspondent Contact Bruce Dunaway
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/28/2020
Decision Date 05/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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