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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation, for degenerative disc disease
510(k) Number K113666
Device Name XIA 3 SPINAL SYSTEM
Original Applicant
STRYKER SPINE
1331 h street nw
12th floor
washington,  DC  20005
Original 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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