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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 K153608
Device Name Vitoss BiModal Bone Graft Substitute Foam Strip
Applicant
Orthovita, Inc.
45 Great Valley Pkwy.
Malver,  PA  19355
Applicant Contact LYNN LUNDY
Correspondent
Orthovita, Inc.
59 Route 17 S.
Allendale,  NJ  07401
Correspondent Contact Meriam Gabera
Regulation Number888.3045
Classification Product Code
MQV  
Date Received12/17/2015
Decision Date 02/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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