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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