KWP · Class II · 21 CFR 888.3050

FDA Product Code KWP: Appliance, Fixation, Spinal Interlaminal

Leading manufacturers include Medtronic Sofamor Danek, Medtronic Sofamor Danek, Inc. and Synthes (Usa).

430
Total
430
Cleared
130d
Avg days
1978
Since
430 devices
337–360 of 430
Cleared Feb 01, 1994
AME(R) RIGID FIXATION SYSTEM
K930531
American Medical Electronics, Inc.
Orthopedic · 364d
Cleared Oct 01, 1993
SENTRY POSTERIOR SPINAL SYSTEM
K930710
Sofamor Danek Mfg., Inc.
Orthopedic · 232d
Cleared Sep 21, 1993
SELBY INSTRUMENTATION
K924474
Advanced Spine Fixation Systems, Inc.
Orthopedic · 383d
Cleared Jun 24, 1993
COTREL - DUBOUSSET SPINE IMPLANTS
K921056
Buckman Co., Inc.
Orthopedic · 476d
Cleared Jun 22, 1993
COMPACT COTREL -- DUBOUSSET SPINE SYSTEM
K921767
Buckman Co., Inc.
Orthopedic · 434d
Cleared Jun 22, 1993
SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST
K921948
Synthes (Usa)
Orthopedic · 421d
Cleared Jun 15, 1993
CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT
K924142
Codman & Shurtleff, Inc.
Orthopedic · 302d
Cleared May 26, 1993
EDWARDS ADJUSTABLE CONNECTORS
K915672
Scientific Spinal , Ltd.
Orthopedic · 526d
Cleared May 18, 1993
LUQUE V SPINAL SYSTEM
K921256
Sofamor Danek Mfg., Inc.
Orthopedic · 428d
Cleared May 18, 1993
ISOLA(R) TANDEM CONNECTOR
K922504
Acromed Corp.
Orthopedic · 356d
Cleared May 18, 1993
AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
K922672
Sofamor Danek Mfg., Inc.
Orthopedic · 348d
Cleared May 18, 1993
PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS
K924381
Cross Medical Products, Inc.
Orthopedic · 260d
Cleared May 18, 1993
TSRH CENTRAL POST HOOKS
K925811
Sofamor Danek Mfg., Inc.
Orthopedic · 285d
Cleared Jan 21, 1993
PARAGON POSTERIOR SPINAL SYSTEM
K920546
Sofamor Danek Mfg., Inc.
Orthopedic · 350d
Cleared Dec 31, 1992
ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION
K920392
Acromed Corp.
Orthopedic · 336d
Cleared Dec 31, 1992
ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR
K921090
Acromed Corp.
Orthopedic · 300d
Cleared Dec 23, 1992
LEAPLAZA FRAME
K922238
Spintech, Inc.
Orthopedic · 224d
Cleared Nov 16, 1992
MODIFIED TSRH CENTRAL POST HOOKS
K922520
Sofamor Danek Mfg., Inc.
Orthopedic · 178d
Cleared Oct 27, 1992
TSRH L CONNECTOR -- MODIFICATION
K923339
Sofamor Danek Mfg., Inc.
Orthopedic · 125d
Cleared Aug 26, 1992
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS
K912837
Kirschner Medical Corp.
Orthopedic · 427d
Cleared Jun 19, 1992
TSRH(TM) LATERAL OFFSET PLATE
K914306
Sofamor Danek Mfg., Inc.
Orthopedic · 268d
Cleared May 12, 1992
TSRH CENTRAL POST HOOKS
K914966
Sofamor Danek Mfg., Inc.
Orthopedic · 189d
Cleared May 05, 1992
THE SELBY SYSTEM
K920102
Advanced Spine Fixation Systems, Inc.
Orthopedic · 117d
Cleared Apr 10, 1992
PWB LUMBOSACRAL SPINE SYSTEM
K920116
Cross Medical Products, Inc.
Orthopedic · 88d