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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K121862
Device Name REX ANTERIOR CERVICAL PLATE SYSTEM
Original Applicant
DIO MEDICAL CO., LTD.
325 n. puente st
unit b
brea,  CA  92821
Original Contact april lee
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/26/2012
Decision Date 10/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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