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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 K141600
Device Name NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
Applicant
Pioneer Surgical Technology, Inc. (Rti Surgical, I
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact SARAH MCINTYRE
Correspondent
Pioneer Surgical Technology, Inc. (Rti Surgical, I
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact SARAH MCINTYRE
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/16/2014
Decision Date 10/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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