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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K122872
Device Name INTERVERTEBRAL BODY FUSION DEVICE
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 Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received09/19/2012
Decision Date 02/28/2013
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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