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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K101170
Device Name ACUTE INNOVATIONS STERNAL FIXATION SYSTEM
Applicant
Acute Innovations, LLC
21421 NW Jacobson Rd.
Suite 700
Hillsboro,  OR  97124
Applicant Contact MARIAH KNIGHT
Correspondent
Acute Innovations, LLC
21421 NW Jacobson Rd.
Suite 700
Hillsboro,  OR  97124
Correspondent Contact MARIAH KNIGHT
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Codes
HWC   JDQ  
Date Received04/26/2010
Decision Date 09/17/2010
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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