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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 K133194
Device Name DIAMOND RATTLESNAKE SYSTEM
Applicant
Eminent Spine
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Applicant Contact LINDA BRADDON
Correspondent
Eminent Spine
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact LINDA BRADDON
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/17/2013
Decision Date 06/26/2014
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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