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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 K100865
Device Name AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
Applicant
Stryker Spine
2 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact KIMBERLY S LANE
Correspondent
Stryker Spine
2 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact KIMBERLY S LANE
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/29/2010
Decision Date 08/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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