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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K150283
Device Name Republic Spine Dark Star Spinal System
Applicant
Republic Spine, LLC
3200 NE 14th St. Causeway Suite 250
Pompano Beach,  FL  33062
Applicant Contact RUSTY MCCARVER
Correspondent
Wagoner Consulting, LLC
P.O. Box 15729
Wilmington,  NC  28408
Correspondent Contact CHERYL L WAGONER
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received02/05/2015
Decision Date 04/29/2015
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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