BIOFLEX


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

Correspodent Contact justin eggleton
Regulation Number 888.3070
Classification Product Code
NQP  
Date Received 08/20/2007
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