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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 K080143
Device Name MODIFICATION TO STRYKER SPINE OASYS 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
MNI  
Subsequent Product Code
KWP  
Date Received01/22/2008
Decision Date 02/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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