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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 K150064
Device Name Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)
Applicant
Orthogem, Ltd.
Biocity, Pennyfoot St.
Nottingham,  GB NG1 1GF
Applicant Contact PAUL Z MARKGRAF
Correspondent
Priory Analysts, Ltd.
15 Rudchesters
Milton Keynes,  GB MK13 0PH
Correspondent Contact ROD RUSTON
Regulation Number888.3045
Classification Product Code
MQV  
Date Received01/13/2015
Decision Date 09/04/2015
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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