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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 K121342
Device Name XIA 4.5 SPINAL SYSTEM
Applicant
Stryker Corp.
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact TIFFANI ROGERS
Correspondent
Stryker Corp.
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact TIFFANI ROGERS
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received05/04/2012
Decision Date 06/22/2012
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
Predetermined Change
Control Plan Authorized		 No
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