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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K090986
Device Name STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)
Applicant
Dfine, Inc.
3047 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact SANDEEP SABOO
Correspondent
Dfine, Inc.
3047 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact SANDEEP SABOO
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
KIH  
Date Received04/07/2009
Decision Date 12/30/2009
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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