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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name posterior metal/polymer spinal system, fusion
510(k) Number K072321
Device Name BIOFLEX
Applicant
BIOSPINE CO., LTD.
1331 H STREET NW, 12TH FLOOR
WASHINGTON,  DC  20005
Applicant Contact JUSTIN EGGLETON
Correspondent
BIOSPINE CO., LTD.
1331 H STREET NW, 12TH FLOOR
WASHINGTON,  DC  20005
Correspondent Contact JUSTIN EGGLETON
Regulation Number888.3070
Classification Product Code
NQP  
Date Received08/20/2007
Decision Date 03/25/2008
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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