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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
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