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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 K062496
Device Name OSTEOPORE TCP
Applicant
Spinecraft, Inc.
2215 Enterprise Dr.
Suite 1504
Westchester,  IL  60154
Applicant Contact AMI AKALLAL-ASSAD
Correspondent
Spinecraft, Inc.
2215 Enterprise Dr.
Suite 1504
Westchester,  IL  60154
Correspondent Contact AMI AKALLAL-ASSAD
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/25/2006
Decision Date 10/19/2006
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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