MNH · Class II · 21 CFR 888.3070

FDA Product Code MNH: Orthosis, Spondylolisthesis Spinal Fixation

Leading manufacturers include Acromed Corp., Medtronic Sofamor Danek, Inc. and Depuyacromed.

309
Total
309
Cleared
127d
Avg days
1995
Since
309 devices
121–144 of 309
Cleared Dec 09, 1996
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608
Synthes (Usa)
Orthopedic · 159d
Cleared Oct 22, 1996
ISOLA TWISTER CONNECTOR
K962645
Acromed Corp.
Orthopedic · 106d
Cleared Sep 17, 1996
VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
K961572
Wrightmedicaltechnologyinc
Orthopedic · 147d
Cleared May 03, 1996
DDS SPINAL SYSTEM
K960107
Encore Orthopedics, Inc.
Orthopedic · 113d
Cleared Apr 18, 1996
WEBB-MORLEY SPINE SYSTEM
K960451
Buckman Co., Inc.
Orthopedic · 79d
Cleared Feb 15, 1996
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
K953915
Depuy, Inc.
Orthopedic · 178d
Cleared Feb 14, 1996
SPINE FIXATION
K943827
Danek Medical, Inc.
Orthopedic · 558d
Cleared Feb 14, 1996
AUGMENT-T POSTERIOR SPINAL SYSTEM
K950717
Sofamor Danek USA,Inc.
Orthopedic · 363d
Cleared Jan 25, 1996
KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS
K950999
Buckman Co., Inc.
Orthopedic · 328d
Cleared Jan 22, 1996
ISOLA SYSTEM
K952236
Acromed Corp.
Orthopedic · 255d
Cleared Oct 30, 1995
TITANIUM DYNA-LOK SPINAL SYSTEM
K953635
Sofamor Danek USA,Inc.
Orthopedic · 89d
Cleared Sep 08, 1995
OSTEONICS SPINAL SYSTEM
K951725
Osteonics Corp.
Orthopedic · 147d
Cleared Sep 01, 1995
ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT
K950865
Smith & Nephew Richards, Inc.
Orthopedic · 186d
Cleared Aug 28, 1995
GDLH POSTERIOR SPINAL SYSTEM
K950596
Sofamor Danek USA,Inc.
Orthopedic · 200d
Cleared Aug 25, 1995
PARAGON POSTERIOR SPINAL SYSTEM
K950955
Sofamor Danek USA,Inc.
Orthopedic · 176d
Cleared Aug 21, 1995
SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM
K951626
Synthes (Usa)
Orthopedic · 136d
Cleared Aug 21, 1995
VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S)
K951657
Acromed Corp.
Orthopedic · 133d
Cleared Aug 21, 1995
SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
K951794
Synthes (Usa)
Orthopedic · 136d
Cleared Aug 11, 1995
WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM
K950074
Wrightmedicaltechnologyinc
Orthopedic · 214d
Cleared Aug 11, 1995
ACROMED PEDICLE SCREW
K951116
Acromed Corp.
Orthopedic · 154d
Cleared Aug 07, 1995
TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)
K946348
Sofamor Danek USA,Inc.
Orthopedic · 220d
Cleared Jun 22, 1995
ISOLA SPINE SYSTEM
K944737
Acromed Corp.
Orthopedic · 269d
Cleared Jun 20, 1995
SIMMONS PLATING SYSTEM BOLT AND SCREW
K930353
Smith & Nephew, Inc.
Orthopedic · 880d
Cleared Jun 14, 1995
ROGOZINSKI SPINAL ROD SYSTEM SCREW
K930298
Smith & Nephew Richards, Inc.
Orthopedic · 874d