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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K181495
Device Name Republic Spine Dark Star Spinal System
Applicant
Republic Spine, LLC
350 Camino Gardens Blvd. Suite 103
Boca Raton,  FL  33432
Applicant Contact James Doulgeris
Correspondent
Republic Spine, LLC
350 Camino Gardens Blvd. Suite 103
Boca Raton,  FL  33432
Correspondent Contact James Doulgeris
Regulation Number888.3070
Classification Product Code
NKB  
Date Received06/06/2018
Decision Date 07/25/2018
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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