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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 K081717
Device Name TRICOS A RESORBABLE BONE SUBSTITUTE
Applicant
Baxter Healthcare Corp
1620 Waulkegan Rd.
Mpgr-Al
Mcgaw Park,  IL  60085
Applicant Contact VALERIE FOLLOWELL
Correspondent
Baxter Healthcare Corp
1620 Waulkegan Rd.
Mpgr-Al
Mcgaw Park,  IL  60085
Correspondent Contact VALERIE FOLLOWELL
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/18/2008
Decision Date 10/10/2008
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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