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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 K072496
Device Name MODIFICATION TO SPACE CPSXL BONE CEMENT
Applicant
Dfine, Inc.
3047 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact ROBERT POSER
Correspondent
Dfine, Inc.
3047 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact ROBERT POSER
Regulation Number888.3027
Classification Product Code
NDN  
Date Received09/05/2007
Decision Date 10/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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