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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Cement Restrictor
510(k) Number K041382
Device Name POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
Applicant
Osteobiologics, Inc.
12500 Network Suite 112
San Antonio,  TX  78249
Applicant Contact GABRIELE G NIEDERAUER, PH.D.
Correspondent
Osteobiologics, Inc.
12500 Network Suite 112
San Antonio,  TX  78249
Correspondent Contact GABRIELE G NIEDERAUER, PH.D.
Regulation Number878.3300
Classification Product Code
JDK  
Date Received05/25/2004
Decision Date 06/17/2005
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
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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