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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with bone graft, cervical
510(k) Number K120486
Device Name AVS AS PEEK SPACER
Original Applicant
STRYKER SPINE
2 pearl court
allendale,  NJ  07401
Original Contact soraya king
Regulation Number888.3080
Classification Product Code
ODP  
Date Received02/17/2012
Decision Date 08/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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