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
169–192 of 430
Cleared Oct 26, 1998
SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM)
K983197
United States Surgical, A Division of Tyco Healthc
Orthopedic · 45d
Cleared Oct 05, 1998
TENOR SPINAL SYSTEM
K982490
Sofamor Danek USA,Inc.
Orthopedic · 80d
Cleared Sep 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K982320
Depuy, Inc.
Orthopedic · 74d
Cleared Sep 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS
K982511
Depuy, Inc.
Orthopedic · 56d
Cleared Sep 08, 1998
BWM SPINE SYSTEM
K982494
Howmedica Corp.
Orthopedic · 53d
Cleared Aug 06, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K982011
DePuy Orthopaedics, Inc.
Orthopedic · 59d
Cleared Jun 10, 1998
AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS
K980121
Aesculap, Inc.
Orthopedic · 147d
Cleared May 20, 1998
OSTEONICS LONG ARM CONTAINMENT RING
K981452
Osteonics Corp.
Orthopedic · 28d
Cleared May 11, 1998
SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM
K980928
Synthes Spine
Orthopedic · 61d
Cleared Apr 16, 1998
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
K980358
Synthes (Usa)
Orthopedic · 77d
Cleared Feb 18, 1998
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K974573
Depuy, Inc.
Orthopedic · 72d
Cleared Oct 16, 1997
CD SPINAL SYSTEM
K964159
Sofamor Danek USA,Inc.
Orthopedic · 365d
Cleared May 08, 1997
EMPOWER ANTERIOR DIRECT SCREWS
K965224
Smith & Nephew Richards, Inc.
Orthopedic · 129d
Cleared Apr 21, 1997
TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM
K964254
Sofamor Danek USA,Inc.
Orthopedic · 179d
Cleared Mar 26, 1997
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM
K964024
Depuy, Inc.
Orthopedic · 170d
Cleared Mar 18, 1997
MOSS MIAMI SPINAL SYSTEM
K962628
Depuy, Inc.
Orthopedic · 256d
Cleared Mar 13, 1997
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145
Depuy, Inc.
Orthopedic · 80d
Cleared Feb 06, 1997
TITANIUM CD HORIZON SPINAL SYSTEM
K962708
Sofamor Danek USA,Inc.
Orthopedic · 209d
Cleared Jan 24, 1997
FINN ROD TO ROD CONNECTOR
K960444
Smith & Nephew Richards, Inc.
Orthopedic · 358d
Cleared Jan 14, 1997
ALPHA POSTERIOR SPINAL SYSTEM
K964275
Sofamor Danek USA,Inc.
Orthopedic · 81d
Cleared Dec 09, 1996
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
K962314
Osteonics Corp.
Orthopedic · 175d
Cleared Dec 05, 1996
CD HORIZON SPINAL SYSTEM
K961633
Sofamor Danek USA,Inc.
Orthopedic · 220d
Cleared Nov 27, 1996
ISOLA PEDIATRIC COMPONENTS
K962984
Acromed Corp.
Orthopedic · 118d
Cleared Nov 14, 1996
ACROMED PEDICLE SCREW
K963639
Acromed Corp.
Orthopedic · 63d