Sofamor Danek Mfg., Inc. - FDA 510(k) Cleared Devices
Recent clearances: SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS, DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY, TSRH SPINAL SCREWS
23
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sofamor Danek Mfg., Inc. Orthopedic ✕
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