Medical Device Manufacturer · US , Memphis , TN

Sofamor Danek Mfg., Inc. - FDA 510(k) Cleared Devices

23 submissions · 12 cleared · Since 1992
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
1-23 of 23
Cleared Dec 19, 1995
SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
K936294 · KWP
Orthopedic · 739d
Cleared Sep 26, 1995
DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY
K930191 · HRX
Orthopedic · 985d
Cleared Jan 20, 1995
TSRH SPINAL SCREWS
K932029 · MNH
Orthopedic · 633d
Cleared Oct 12, 1993
DANEK TISSUE CUTTING AND REMOVAL SYSTEM
K922486 · HRX
Orthopedic · 503d
Cleared Oct 01, 1993
SENTRY POSTERIOR SPINAL SYSTEM
K930710 · KWP
Orthopedic · 232d
Cleared Oct 01, 1993
SENTRY ANTERIOR SPINAL SYSTEM
K930807 · KWQ
Orthopedic · 227d
Cleared May 19, 1993
Z-PLATE ANTERIOR FIXATION SYSTEM
K922543 · KWQ
Orthopedic · 355d
Cleared May 19, 1993
CROSSLINK AXIAL AND OFFSET PLATES
K923242 · KWQ
Orthopedic · 321d
Cleared May 18, 1993
LUQUE V SPINAL SYSTEM
K921256 · KWP
Orthopedic · 428d
Cleared May 18, 1993
AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
K922672 · KWP
Orthopedic · 348d
Cleared May 18, 1993
TSRH CENTRAL POST HOOKS
K925811 · KWP
Orthopedic · 285d
Cleared Apr 08, 1993
DANEK TISSUE RESECTING SYSTEM
K925577 · HRX
Orthopedic · 156d
Cleared Mar 24, 1993
TITANIUM SONGER CABLE SYSTEM
K925812 · JDQ
Orthopedic · 132d
Cleared Feb 08, 1993
RESORABPLUG
K920118 · LZN
Orthopedic · 392d
Cleared Jan 21, 1993
PARAGON POSTERIOR SPINAL SYSTEM
K920546 · KWP
Orthopedic · 350d
Cleared Dec 17, 1992
STERILE DYNA LOK ANTERIOR PLATING SYSTEM
K923446 · KWQ
Orthopedic · 156d
Cleared Dec 17, 1992
RECONSTRUCTION PLATE SYSTEM
K924085 · HRS
Orthopedic · 126d
Cleared Nov 16, 1992
MODIFIED TSRH CENTRAL POST HOOKS
K922520 · KWP
Orthopedic · 178d
Cleared Nov 06, 1992
ANTERIOR CERVICAL PLATE SYSTEM
K922087 · KWQ
Orthopedic · 186d
Cleared Oct 27, 1992
TSRH L CONNECTOR -- MODIFICATION
K923339 · KWP
Orthopedic · 125d
Cleared Jun 19, 1992
TSRH(TM) LATERAL OFFSET PLATE
K914306 · KWP
Orthopedic · 268d
Cleared May 12, 1992
TSRH CENTRAL POST HOOKS
K914966 · KWP
Orthopedic · 189d
Cleared Apr 08, 1992
TITANIUM ALLOY SONGER CABLE SYSTEM
K920201 · JDQ
Orthopedic · 84d
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