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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 K030554
FOIA Releasable 510(k) K030554
Device Name CALLOS
Applicant
Skeletal Kinetics, LLC
555 13th St., NW
Washington,  DC  20004
Applicant Contact HOWARD HOLSTEIN
Correspondent
Skeletal Kinetics, LLC
555 13th St., NW
Washington,  DC  20004
Correspondent Contact HOWARD HOLSTEIN
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/21/2003
Decision Date 05/20/2003
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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