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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 K051775
Device Name OSTEOMIMETIC SYNTHETIC BONE MATRIX
Applicant
Biomimetic Pharmaceuticals, Inc.
389 A Nichol Mill Ln.
Franklin,  TN  37067
Applicant Contact SANDRA WILLIAMSON
Correspondent
Biomimetic Pharmaceuticals, Inc.
389 A Nichol Mill Ln.
Franklin,  TN  37067
Correspondent Contact SANDRA WILLIAMSON
Regulation Number888.3045
Classification Product Code
MQV  
Date Received07/01/2005
Decision Date 09/06/2005
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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