Danek Medical, Inc. - FDA 510(k) Cleared Devices
56
Total
47
Cleared
0
Denied
40 devices
Cleared
Feb 18, 2000
BONE GRAFT WASHER, MODEL 9090114 - 9090118
Orthopedic
73d
Cleared
Feb 03, 2000
CD HORIZON SPINAL SYSTEM
Orthopedic
85d
Cleared
Dec 15, 1999
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
Orthopedic
30d
Cleared
May 28, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
Orthopedic
25d
Cleared
Mar 10, 1999
MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
Orthopedic
15d
Cleared
Jan 19, 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
Orthopedic
158d
Cleared
Jan 06, 1999
MODIFICATION OF TSRH SPINAL SYSTEM
Orthopedic
16d
Cleared
Jul 13, 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
Orthopedic
24d
Cleared
Mar 20, 1998
TOWNLEY PEDICLE SCREW PLATING SYSTEM
Orthopedic
395d
Cleared
Feb 14, 1996
SPINE FIXATION
Orthopedic
558d
Cleared
May 10, 1995
INCLUSIVE ENDOSCOPE
Orthopedic
302d
Cleared
Nov 21, 1994
DANEKSCOPE OPTI-PROBE
Orthopedic
118d
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