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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 K160604
Device Name Cure™ Anterior Cervical Plate (ACP) 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 Received03/02/2016
Decision Date 07/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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