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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 K163621
Device Name Vitoss Bioactive (BA) Injectable
Applicant
Orthovita, Inc.
45 Great Valley Pkwy.
Malver,  PA  19355
Applicant Contact John Rossman
Correspondent
Stryker Corporation
59 Route 17 S.
Allendale,  NJ  07401
Correspondent Contact John Rossman
Regulation Number888.3045
Classification Product Code
MQV  
Date Received12/22/2016
Decision Date 05/02/2017
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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