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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K110926
Device Name BONE PLATE; BONE SCREW
Applicant
Biomaterials Korea, Inc.
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Applicant Contact Kevin Walls
Correspondent
Biomaterials Korea, Inc.
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Correspondent Contact Kevin Walls
Regulation Number872.4760
Classification Product Code
JEY  
Date Received04/01/2011
Decision Date 12/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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