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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 K090175
Device Name UNITY BETA PLLA SYSTEM
Applicant
Bonutti Research, Inc.
2600 S. Raney
P.O. Box 1367
Effingham,  IL  62401
Applicant Contact PATRICK BALSMANN
Correspondent
Bonutti Research, Inc.
2600 S. Raney
P.O. Box 1367
Effingham,  IL  62401
Correspondent Contact PATRICK BALSMANN
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received01/23/2009
Decision Date 09/10/2009
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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