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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 K050624
Device Name STRYKER SPINE AVS PL PEEK SPACER
Applicant
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact SIMONA VOIC
Correspondent
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact SIMONA VOIC
Regulation Number888.3060
Classification Product Code
MQP  
Date Received03/11/2005
Decision Date 04/11/2005
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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