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
265–288 of 430
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 26, 1997
BACFIX SPINAL FIXATION SYSTEM
K964404
Spinal Concepts, Inc.
Orthopedic · 142d
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
Cleared Oct 01, 1996
COTREL-DUBOUSSET (CD) SPINAL
K955807
Sofamor Danek USA,Inc.
Orthopedic · 284d
Cleared Mar 27, 1996
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM
K955365
Sofamor Danek USA,Inc.
Orthopedic · 126d
Cleared Mar 15, 1996
J.B. S. C1-C2 CLAMP
K955864
J.B.S., S.A.
Orthopedic · 79d
Cleared Mar 13, 1996
BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)
K955927
Arcan Orthopaedic Corp.
Orthopedic · 82d
Cleared Mar 11, 1996
ROGOZINSKI THORACOLUMBAR SPINAL ROD
K954696
Smith & Nephew Richards, Inc.
Orthopedic · 151d
Cleared Feb 16, 1996
TITANIUM MOSS MIAMI SPINAL SYSTEM
K955348
Depuy, Inc.
Orthopedic · 87d
Cleared Feb 14, 1996
MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS
K951846
Alphatec Mfg., Inc.
Orthopedic · 300d
Cleared Feb 09, 1996
CD LIBERTY POSTERIOR SPINCAL SYSTEM
K951164
Sofamor Danek USA,Inc.
Orthopedic · 332d
Cleared Feb 09, 1996
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K955173
Osteotech, Inc.
Orthopedic · 88d
Cleared Jan 25, 1996
CENTRA-LINE GRAPPLE, VARIFIX SYSTEM
K954770
Advanced Spine Fixation Systems, Inc.
Orthopedic · 100d
Cleared Jan 16, 1996
TITANIUM GDLH POSTERIOR SPINAL SYSTEM
K954645
Sofamor Danek USA,Inc.
Orthopedic · 98d