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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Vertebroplasty (Does Not Contain Cement)
510(k) Number K051820
Device Name PARALLAX EZFLOW CEMENT DELIVERY SYSTEM
Applicant
Arthrocare Corp.
680 Vaqueros Ave.
Sunnyvale,  CA  94085
Applicant Contact VALERIE DEFIESTA-NG
Correspondent
Arthrocare Corp.
680 Vaqueros Ave.
Sunnyvale,  CA  94085
Correspondent Contact VALERIE DEFIESTA-NG
Regulation Number888.4200
Classification Product Code
OAR  
Date Received07/05/2005
Decision Date 09/06/2005
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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