NDN · Class II · 21 CFR 888.3027

FDA Product Code NDN: Cement, Bone, Vertebroplasty

Leading manufacturers include Arthrocare Corp., Stryker Corporation and Disc-O-Tech Medical Technologies, Ltd..

108
Total
108
Cleared
154d
Avg days
2004
Since
108 devices
73–96 of 108
Cleared Dec 21, 2007
MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
K071375
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 219d
Cleared Dec 07, 2007
STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
K072118
Stryker Corp.
Orthopedic · 128d
Cleared Nov 20, 2007
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
K072133
Cardinal Health, Inc.
Orthopedic · 110d
Cleared May 04, 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K070527
Medtronic Sofamor Danek
Orthopedic · 70d
Cleared Mar 13, 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K063248
Medtronic Sofamor Danek
Orthopedic · 138d
Cleared Nov 03, 2006
CONFIDENCE FENESTRATED INTRODUCER NEEDLE
K063067
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 28d
Cleared Sep 14, 2006
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
K062424
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 27d
Cleared Jul 12, 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
K060425
Arthrocare Corp.
Orthopedic · 145d
Cleared Jul 03, 2006
STAXX FX SYSTEM
K053336
Spine Wave, Inc.
Orthopedic · 214d
Cleared Jun 21, 2006
CONFIDENCE HIGH VISCOSITY BONE CEMENT
K060300
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 135d
Cleared Mar 17, 2006
SPINE-FIX BIOMIMETIC BONE CEMENT
K043593
Teknimed, S.A.
Orthopedic · 443d
Cleared Mar 13, 2006
EBI VERTEBROPLASTY SYSTEMS
K060148
Ebi, L.P.
Orthopedic · 53d
Cleared Jan 25, 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
K053180
Arthrocare Corp.
Orthopedic · 72d
Cleared Nov 08, 2005
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691
Cook, Inc.
Orthopedic · 405d
Cleared Jul 15, 2005
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
K043406
Depuy Spine, Inc.
Orthopedic · 217d
Cleared Jun 17, 2005
PARALLAX ACRYLIC RESIN WITH TRACERS TA
K050864
Arthrocare Corp.
Orthopedic · 73d
Cleared Jun 09, 2005
MENDEC SPINE
K042415
Tecres S.P.A.
Orthopedic · 275d
Cleared May 11, 2005
RADIOPAQUE BONE CEMENT
K043518
Cardinalhealth
Orthopedic · 142d
Cleared Jan 14, 2005
CONCORD Radiopaque Bone Cement
K042168
Globus Medical, Inc.
Orthopedic · 158d
Cleared Dec 27, 2004
PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
K042947
Arthrocare Corp.
Orthopedic · 62d
Cleared Jul 07, 2004
KYPHX HV-R BONE CEMENT, MODEL C01A
K041584
Kyphon, Inc.
Orthopedic · 23d