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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
510(k) Number K052971
Device Name STRYKER SPINE TRIO SPINAL FIXATION 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 Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received10/24/2005
Decision Date 11/16/2005
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
Recalls CDRH Recalls
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