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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 K142463
Device Name Bio2 CLM BG Bioactive Scaffold
Applicant
Bio2 Technologies, Inc.
12 R Cabot Rd.
Woburn,  MA  01801
Applicant Contact Janet Krevolin, PhD
Correspondent
Bio2 Technologies, Inc.
12 R Cabot Rd.
Woburn,  MA  01801
Correspondent Contact Janet Krevolin, PhD
Regulation Number888.3045
Classification Product Code
MQV  
Date Received09/02/2014
Decision Date 12/18/2014
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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