Spine Wave, Inc. - FDA 510(k) Cleared Devices
57
Total
57
Cleared
0
Denied
57 devices
Cleared
Mar 05, 2015
Leva(TM) Spacer System
Orthopedic
28d
Cleared
Feb 19, 2015
StaXx(R) XD System
Orthopedic
126d
Cleared
Jan 26, 2015
LEVA (TM) SPACER SYSTEM
Orthopedic
189d
Cleared
Jan 16, 2015
Proficient (TM) Facet Screw Spine System
Orthopedic
93d
Cleared
Oct 23, 2014
ABACUS (TM) SPACER SYSTEM
Orthopedic
83d
Cleared
Apr 07, 2014
ABACUS TM SPACER SYSTEM
Orthopedic
95d
Cleared
Jan 10, 2014
ANNEXTM ADJACENT LEVEL SYSTEM
Orthopedic
162d
Cleared
Dec 06, 2013
STAXX(R) SYSTEM
Orthopedic
49d
Cleared
Oct 04, 2013
STAXX IBL SYSTEM
Orthopedic
35d
Cleared
Aug 20, 2013
STAXX IBL SYSTEM
Orthopedic
125d
Cleared
Aug 09, 2013
CAPSURE PS SYSTEM
Orthopedic
28d
Cleared
Apr 11, 2013
STAXX(R) IB SYSTEM
Orthopedic
153d
Cleared
Oct 11, 2012
CAPSURE(R) PS SYSTEM
Orthopedic
77d
Cleared
Aug 29, 2012
STAXX XD SYSTEM
Orthopedic
62d
Cleared
Jun 07, 2012
CAPSURE(R) PS SYSTEM
Orthopedic
97d
Cleared
Dec 13, 2011
STAXX(R) XD SYSTEM
Orthopedic
207d
Cleared
Aug 31, 2011
CAPSURE(R) PS SYSTEM
Orthopedic
56d
Cleared
Aug 19, 2011
STAXX XDL SYSTEM
Orthopedic
368d
Cleared
Jul 19, 2011
STAXXSD SYSTEM
Orthopedic
53d
Cleared
Nov 30, 2010
STAXX(R) XD SYSTEM
Orthopedic
74d
Cleared
Sep 10, 2010
STAXX XD SYSTEM
Orthopedic
126d
Cleared
Jun 04, 2010
MIS SYSTEM
Orthopedic
93d
Cleared
Feb 12, 2010
MODIFICATION TO CAPSURE PS SYSTEM
Orthopedic
28d
Cleared
Sep 03, 2009
STAXX XD SYSTEM
Orthopedic
206d
Cleared
Jan 13, 2009
CAPSURE PS SYSTEM
Orthopedic
28d