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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 K080758
Device Name AVS PL PEEK SPACERS, MODELS 48351 AND 48353
Applicant
Stryker Corp.
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact VIKKI M O'CONNOR
Correspondent
Stryker Corp.
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact VIKKI M O'CONNOR
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/18/2008
Decision Date 03/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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