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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K113044
Device Name SYNTHES MIRS
Applicant
Synthes Spine
1302 Wrights Ln. E.
West Chester,  PA  19380
Applicant Contact HEATHER GUERIN
Correspondent
Synthes Spine
1302 Wrights Ln. E.
West Chester,  PA  19380
Correspondent Contact HEATHER GUERIN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received10/12/2011
Decision Date 12/21/2011
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
Recalls CDRH Recalls
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