Sofamor Danek USA,Inc. - FDA 510(k) Cleared Devices
41
Total
26
Cleared
0
Denied
39 devices
Cleared
May 10, 2000
COLORADO II SPINAL SYSTEM
Orthopedic
408d
Cleared
Mar 30, 2000
COLORADO II SPINAL SYSTEM
Orthopedic
479d
Cleared
Sep 21, 1999
CD HORIZON SPINAL SYSTEM
Orthopedic
21d
Cleared
Sep 14, 1999
DANEK PLATE AND SCREW SYSTEM
Orthopedic
169d
Cleared
Aug 27, 1999
DYNA-LOK PLUS SPINAL SYSTEM
Orthopedic
141d
Cleared
May 19, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
Orthopedic
29d
Cleared
Jan 28, 1999
CD HORIZON SPINAL SYSTEM
Orthopedic
261d
Cleared
Dec 18, 1998
CD SPINAL SYSTEM
Orthopedic
332d
Cleared
Dec 16, 1998
DYNA-LOK SPINAL SYSTEM
Orthopedic
58d
Cleared
Nov 12, 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
Orthopedic
22d
Cleared
Oct 21, 1998
TSRH SPINAL SYSTEM
Orthopedic
56d
Cleared
Oct 05, 1998
TENOR SPINAL SYSTEM
Orthopedic
80d
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