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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K091946
Device Name VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX
Applicant
Stryker Spine
2 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact KIMBERLY LANE
Correspondent
Stryker Spine
2 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact KIMBERLY LANE
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/30/2009
Decision Date 09/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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