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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 K121786
Device Name DYMAXEON SPINE SYSTEM
Applicant
B2B SPINE PTY LTD
1331 H ST NW
12 FL
WASHINGTON,  DC  20005
Applicant Contact JUSTIN EGGLETON
Correspondent
B2B SPINE PTY LTD
1331 H ST NW
12 FL
WASHINGTON,  DC  20005
Correspondent Contact JUSTIN EGGLETON
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received06/18/2012
Decision Date 11/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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