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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 K101446
Device Name EMERALD SPINAL SYSTEM
Applicant
Mazor Surgical Technologies , Ltd.
1331 H St. NW
12th Floor
Washington,  DC  20005
Applicant Contact JUSTIN EGGLETON
Correspondent
Mazor Surgical Technologies , Ltd.
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact JUSTIN EGGLETON
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
MNI   NKB  
Date Received05/24/2010
Decision Date 01/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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