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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K093078
Device Name UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS
Applicant
BONUTTI RESEARCH, INC.
2600 SOUTH RANEY
P.O. BOX 1367
EFFINGHAM,  IL  62401
Applicant Contact PATRICK G BALSMANN
Correspondent
BONUTTI RESEARCH, INC.
2600 SOUTH RANEY
P.O. BOX 1367
EFFINGHAM,  IL  62401
Correspondent Contact PATRICK G BALSMANN
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received09/30/2009
Decision Date 06/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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