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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
Applicant
Dio Medical Co., Ltd.
325 N. Puente St., Unit B
Brea,  CA  92821
Applicant Contact APRIL LEE
Correspondent
Dio Medical Co., Ltd.
325 N. Puente St., Unit B
Brea,  CA  92821
Correspondent Contact APRIL LEE
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/26/2012
Decision Date 10/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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