Medtronic Sofamor Danek USA, Inc. - FDA 510(k) Cleared Devices
169
Total
158
Cleared
0
Denied
154 devices
Cleared
Nov 17, 2010
CD HORIZON SPINAL SYSTEM
Orthopedic
71d
Cleared
Oct 21, 2010
T2 XVBR 1.5 SPINAL SYSTEM
Orthopedic
196d
Cleared
Jun 22, 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
Orthopedic
64d
Cleared
Dec 15, 2009
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
Orthopedic
133d
Cleared
Sep 21, 2009
T2 SPINAL SYSTEM
Orthopedic
89d
Cleared
Sep 02, 2009
MODIFICATION TO CD HORIZON SPINAL SYSTEM
Orthopedic
63d
Cleared
Jan 16, 2009
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
Orthopedic
120d
Cleared
Oct 16, 2008
MODIFICATION TO: CAPSTONE SPINAL SYSTEM
Orthopedic
28d
Cleared
May 15, 2008
PEEK PREVAIL CERVICAL INTERBODY DEVICE
Orthopedic
174d
Cleared
Apr 30, 2008
MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
Orthopedic
71d
Cleared
Apr 24, 2008
CAPSTONE SPINAL SYSTEM
Orthopedic
153d
Cleared
Nov 01, 2007
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
Orthopedic
164d
Cleared
Sep 18, 2007
MODIFICATION TO:TSRH SPINAL SYSTEM
Orthopedic
29d
Cleared
Oct 07, 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
Orthopedic
49d
Cleared
Jul 21, 2005
CD HORIZON SPINAL SYSTEM
Orthopedic
28d
Cleared
Jun 14, 2005
CD HORIZON SPINAL SYSTEM
Orthopedic
75d
Cleared
May 17, 2005
CD HORIZON SPINAL SYSTEM
Orthopedic
28d
Cleared
May 12, 2005
BASIS SPINAL SYSTEM
Orthopedic
17d
Cleared
Feb 10, 2005
CD HORIZON SPINAL SYSTEM
Orthopedic
28d
Cleared
Jul 01, 2004
CD HORIZON SPINAL SYSTEM
Orthopedic
29d
Cleared
Jun 27, 2003
CD HORIZON SPINAL SYSTEM
Orthopedic
30d
Cleared
Jul 09, 2002
TSRH SPINAL SYSTEM
Orthopedic
88d
Cleared
Mar 07, 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
Orthopedic
213d
Cleared
Oct 10, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
Orthopedic
229d
Cleared
Aug 03, 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
Orthopedic
84d
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