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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 K021684
Device Name THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
Applicant
Bioplate, Inc.
6911 Melrose Ave.
Los Angeles,  CA  90038
Applicant Contact CAROL E JONES
Correspondent
Bioplate, Inc.
6911 Melrose Ave.
Los Angeles,  CA  90038
Correspondent Contact CAROL E JONES
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
HRS  
Date Received05/22/2002
Decision Date 06/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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