Sofamor Danek Mfg., Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Sofamor Danek Mfg., Inc. - FDA 510(k) Cleared Devices
23
Total
12
Cleared
0
Denied
Sofamor Danek Mfg., Inc. has 12 FDA 510(k) cleared orthopedic devices. Based in Memphis, US.
Historical record: 12 cleared submissions from 1992 to 1995.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Sofamor Danek Mfg., Inc.
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