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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 K110538
Device Name PRO FIXATION SYSTEM
Applicant
Synovis Orthopedic & Woundcare
6 Jenner, Suite 150
Irvine,  CA  92618
Applicant Contact AMY BOUCLY
Correspondent
Synovis Orthopedic & Woundcare
6 Jenner, Suite 150
Irvine,  CA  92618
Correspondent Contact AMY BOUCLY
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MBI  
Date Received02/25/2011
Decision Date 07/12/2011
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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