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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 K051406
Device Name OSTEOCURE RESORBABLE BEAD KIT
Applicant
Nexa Orthopedics, Inc.
990 Park Center Dr., Suite H
Vista,  CA  92081
Applicant Contact LOUISE M FOCHT
Correspondent
Nexa Orthopedics, Inc.
990 Park Center Dr., Suite H
Vista,  CA  92081
Correspondent Contact LOUISE M FOCHT
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/31/2005
Decision Date 08/01/2005
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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