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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 K113666
FOIA Releasable 510(k) K113666
Device Name XIA 3 SPINAL SYSTEM
Applicant
STRYKER SPINE
1331 H STREET NW
12TH FLOOR
WASHINGTON,  DC  20005
Applicant Contact G. STIEGMAN
Correspondent
STRYKER SPINE
1331 H STREET NW
12TH FLOOR
WASHINGTON,  DC  20005
Correspondent Contact G. STIEGMAN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI   OSH  
Date Received12/13/2011
Decision Date 08/28/2012
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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