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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 K980817
Device Name PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L
Applicant
Interpore Intl.
181 Technology Dr.
Irvine,  CA  92618
Applicant Contact DAVID P BALDING
Correspondent
Interpore Intl.
181 Technology Dr.
Irvine,  CA  92618
Correspondent Contact DAVID P BALDING
Regulation Number888.3045
Classification Product Code
MQV  
Date Received03/03/1998
Decision Date 09/25/1998
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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