Sofamor Danek Mfg., Inc. - FDA 510(k) Cleared Devices
23
Total
12
Cleared
0
Denied
23 devices
Cleared
Dec 19, 1995
SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
Orthopedic
739d
Cleared
Sep 26, 1995
DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY
Orthopedic
985d
Cleared
Jan 20, 1995
TSRH SPINAL SCREWS
Orthopedic
633d
Cleared
Oct 12, 1993
DANEK TISSUE CUTTING AND REMOVAL SYSTEM
Orthopedic
503d
Cleared
Oct 01, 1993
SENTRY POSTERIOR SPINAL SYSTEM
Orthopedic
232d
Cleared
Oct 01, 1993
SENTRY ANTERIOR SPINAL SYSTEM
Orthopedic
227d
Cleared
May 19, 1993
Z-PLATE ANTERIOR FIXATION SYSTEM
Orthopedic
355d
Cleared
May 19, 1993
CROSSLINK AXIAL AND OFFSET PLATES
Orthopedic
321d
Cleared
May 18, 1993
LUQUE V SPINAL SYSTEM
Orthopedic
428d
Cleared
May 18, 1993
AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
Orthopedic
348d
Cleared
May 18, 1993
TSRH CENTRAL POST HOOKS
Orthopedic
285d
Cleared
Apr 08, 1993
DANEK TISSUE RESECTING SYSTEM
Orthopedic
156d
Cleared
Mar 24, 1993
TITANIUM SONGER CABLE SYSTEM
Orthopedic
132d
Cleared
Feb 08, 1993
RESORABPLUG
Orthopedic
392d
Cleared
Jan 21, 1993
PARAGON POSTERIOR SPINAL SYSTEM
Orthopedic
350d
Cleared
Dec 17, 1992
STERILE DYNA LOK ANTERIOR PLATING SYSTEM
Orthopedic
156d
Cleared
Dec 17, 1992
RECONSTRUCTION PLATE SYSTEM
Orthopedic
126d
Cleared
Nov 16, 1992
MODIFIED TSRH CENTRAL POST HOOKS
Orthopedic
178d
Cleared
Nov 06, 1992
ANTERIOR CERVICAL PLATE SYSTEM
Orthopedic
186d
Cleared
Oct 27, 1992
TSRH L CONNECTOR -- MODIFICATION
Orthopedic
125d
Cleared
Jun 19, 1992
TSRH(TM) LATERAL OFFSET PLATE
Orthopedic
268d
Cleared
May 12, 1992
TSRH CENTRAL POST HOOKS
Orthopedic
189d
Cleared
Apr 08, 1992
TITANIUM ALLOY SONGER CABLE SYSTEM
Orthopedic
84d