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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 K100952
Device Name MODIFICATION TO SYNTHES MATRIX SYSTEM
Applicant
SYNTHES SPINE
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact JASON LIPMAN
Correspondent
SYNTHES SPINE
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact JASON LIPMAN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received04/06/2010
Decision Date 08/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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