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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K043473
Device Name MODIFICATION TO XIA SPINAL SYSTEM
Applicant
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact SIMONA VOIC
Correspondent
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact SIMONA VOIC
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received12/16/2004
Decision Date 01/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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