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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 K000515
Device Name PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
Applicant
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618
Applicant Contact PROSIE REY-FESSLER
Correspondent
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618
Correspondent Contact PROSIE REY-FESSLER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/16/2000
Decision Date 09/15/2000
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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