Spine Wave, Inc. - FDA 510(k) Cleared Devices
59
Total
59
Cleared
0
Denied
59 devices
Cleared
Sep 03, 2009
STAXX XD SYSTEM
Orthopedic
206d
Cleared
Jan 13, 2009
CAPSURE PS SYSTEM
Orthopedic
28d
Cleared
Dec 11, 2008
CAPSURE(R) PS SYSTEM
Orthopedic
28d
Cleared
May 12, 2008
CAPSURE PS (R) SPINE SYSTEM
Orthopedic
12d
Cleared
Apr 13, 2007
MODIFICATION TO STAXX FX SYSTEM
Orthopedic
133d
Cleared
Apr 05, 2007
CAPSURE PEDICLE SCREW SYSTEM
Orthopedic
70d
Cleared
Jul 03, 2006
STAXX FX SYSTEM
Orthopedic
214d
Cleared
Apr 27, 2006
STAXX XD SYSTEM
Orthopedic
212d
Cleared
Jun 24, 2004
WAFER SYSTEM
Orthopedic
254d