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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
  No 510(k) holder with active listings identified
Current 510(k) Holder
No 510(k) holder with active listings identified
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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