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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 K093342
Device Name BIOGENNIX RPC
Applicant
Biogennix, LLC
19200 Von Karman Ave.
Suite 400
Irvine,  CA  92612
Applicant Contact EDWIN C SHORS
Correspondent
Biogennix, LLC
19200 Von Karman Ave.
Suite 400
Irvine,  CA  92612
Correspondent Contact EDWIN C SHORS
Regulation Number888.3045
Classification Product Code
MQV  
Date Received10/26/2009
Decision Date 07/29/2010
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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