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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 K070351
Device Name SPACE 360 DELIVERY SYSTEM
Applicant
Dfine, Inc.
19450 Stevens Creek Blvd.
Suite 100
Cupertino,  CA  95014
Applicant Contact ROBERT POSER
Correspondent
Dfine, Inc.
19450 Stevens Creek Blvd.
Suite 100
Cupertino,  CA  95014
Correspondent Contact ROBERT POSER
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
KIH  
Date Received02/06/2007
Decision Date 06/29/2007
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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