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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 K150184
Device Name Dymaxeon Spine System
Applicant
Back 2 Basics Direct, LLC
6701 Rockside Rd., Suite 200
Independence,  OH  44131
Applicant Contact Scot Miller
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact Samuel Pollard
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received01/27/2015
Decision Date 06/15/2015
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
Recalls CDRH Recalls
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