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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 K082419
Device Name REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1
Applicant
Intra-Lock International, Inc.
6560 W. Rogers Cir. Suite 24
Boca Raton,  FL  33487
Applicant Contact JEFFREY SAKOFF
Correspondent
Intra-Lock International, Inc.
6560 W. Rogers Cir. Suite 24
Boca Raton,  FL  33487
Correspondent Contact JEFFREY SAKOFF
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
LYC  
Date Received08/22/2008
Decision Date 05/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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