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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 K102235
Device Name MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
Applicant
STRYKER SPINE
2 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact CURTIS TRUESDALE
Correspondent
STRYKER SPINE
2 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact CURTIS TRUESDALE
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received08/09/2010
Decision Date 08/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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