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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K190889
Device Name Republic Spine Restore Cervical Interbody Fusion System
Applicant
Republic Spine, LLC
2424 N. Federal Hwy.
Boca Raton,  FL  33431
Applicant Contact James Doulgeris
Correspondent
Republic Spine, LLC
2424 N. Federal Hwy.
Boca Raton,  FL  33431
Correspondent Contact James Doulgeris
Regulation Number888.3080
Classification Product Code
ODP  
Date Received04/05/2019
Decision Date 06/19/2019
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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