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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K070897
Device Name BONEMEDIK, AND BONEMEDIK-S
Applicant
Meta Biomed Co., Ltd.
414-12 Mo Choong Dong
Chong Ju City,
Choong Chong Buk Do,  KR
Applicant Contact TAE-HOON KIM
Correspondent
Meta Biomed Co., Ltd.
414-12 Mo Choong Dong
Chong Ju City,
Choong Chong Buk Do,  KR
Correspondent Contact TAE-HOON KIM
Regulation Number888.3045
Classification Product Code
MQV  
Date Received04/02/2007
Decision Date 09/17/2007
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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