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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 K170989
Device Name Dymaxeon Spine System
Applicant
Back 2 Basics Direct, LLC
6701 Rockside Rd., Suite 200
Independence,  OH  44131
Applicant Contact Mitchell Bass
Correspondent
Jalex Medical
30311 Clemens Rd. Suite #3d
Westlake,  OH  44145
Correspondent Contact Melissa Spang
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received04/03/2017
Decision Date 05/22/2017
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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