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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 K090387
Device Name KAINOS+
Applicant
Signus Medizintechnik GmbH
8202 Sherman Rd.
Chesterland,  OH  44026
Applicant Contact KAREN WARDEN
Correspondent
Signus Medizintechnik GmbH
8202 Sherman Rd.
Chesterland,  OH  44026
Correspondent Contact KAREN WARDEN
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/17/2009
Decision Date 09/28/2009
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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