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FDA 510(k) Applications Submitted by DFINE, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K070351
02/06/2007
SPACE 360 DELIVERY SYSTEM
DFINE, INC.
K072496
09/05/2007
MODIFICATION TO SPACE CPSXL BONE CEMENT
DFINE, INC.
K061531
06/02/2006
SPACE CPSXL BONE CEMENT
DFINE, INC.
K090986
04/07/2009
STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)
DFINE, INC.
K091310
05/04/2009
ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682
DFINE, INC.
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