Dfine, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ABLATION INSTRUMENT, MODEL 1635, STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT), MODIFICATION TO SPACE CPSXL BONE CEMENT
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dfine, Inc. Orthopedic ✕
4 devices
Cleared
Dec 30, 2009
STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM...
Orthopedic
267d
Cleared
Oct 05, 2007
MODIFICATION TO SPACE CPSXL BONE CEMENT
Orthopedic
30d
Cleared
Jun 29, 2007
SPACE 360 DELIVERY SYSTEM
Orthopedic
143d
Cleared
Aug 30, 2006
SPACE CPSXL BONE CEMENT
Orthopedic
89d