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
145–168 of 430
Cleared Feb 16, 2005
TECHTONIX SYSTEM
K050189
Stryker Spine
Orthopedic · 20d
Cleared Feb 10, 2005
CD HORIZON SPINAL SYSTEM
K050079
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jan 14, 2005
ISSYS PEDICLE SCREW SYSTEM
K043522
Custom Spine, Inc.
Orthopedic · 25d
Cleared Jan 12, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K043473
Stryker Spine
Orthopedic · 27d
Cleared Jan 10, 2005
DENALI SPINE SYSTEM
K042635
K2m, LLC
Orthopedic · 105d
Cleared Jan 07, 2005
GLAXY 3.2 SPINAL SYSTEM
K043020
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Dec 21, 2004
VERTEX RECONSTRUCTION SYSTEM
K042789
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared Dec 21, 2004
MODIFICATION TO ALTIUS OCT SYSTEM
K043229
Interpore Cross Intl.
Orthopedic · 29d
Cleared Dec 17, 2004
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X
K043355
Sintea Biotech, Inc.
Orthopedic · 11d
Cleared Oct 27, 2004
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K042673
Alphatec/Nexmed
Orthopedic · 28d
Cleared Oct 08, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042524
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Oct 07, 2004
EXCELLA-M SPINAL SYSTEM
K042143
Innovasis, Inc.
Orthopedic · 59d
Cleared Oct 07, 2004
VERTEX RECONSTRUCTION SYSTEM
K042498
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Oct 07, 2004
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
K042508
Depuy Spine, Inc.
Orthopedic · 22d
Cleared Oct 01, 2004
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K041808
Endius, Inc.
Orthopedic · 87d
Cleared Oct 01, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042402
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 24, 2004
ST360 SPINAL FIXATION SYSTEM
K041925
Zimmer Spine, Inc.
Orthopedic · 67d
Cleared Sep 16, 2004
CORAL SPINAL SYSTEM
K041592
Theken Surgical
Orthopedic · 94d
Cleared Sep 15, 2004
CD HORIZON SPINAL SYSTEM
K041862
Medtronic Sofamor Danek
Orthopedic · 68d
Cleared Jul 19, 2004
EXPEDIUM SPINE SYSTEM
K041119
Depuy Spine, Inc.
Orthopedic · 81d
Cleared Jul 01, 2004
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
K040096
Spinal Concepts, Inc.
Orthopedic · 163d
Cleared Jul 01, 2004
SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT
K041449
Interpore Cross Intl.
Orthopedic · 30d
Cleared Jun 10, 2004
MODIFICATION TO TSRH SPINAL SYSTEM
K041282
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Apr 14, 2004
ALTIUS OCT SYSTEM
K033961
Interpore Cross Intl.
Orthopedic · 114d