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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, lumbar
510(k) Number K083661
Device Name AVS TL PEEK SPACERS
Applicant
STRYKER CORP.
2 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact KIMBERLY LANE
Correspondent
STRYKER CORP.
2 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact KIMBERLY LANE
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/10/2008
Decision Date 02/27/2009
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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