NDN · Class II · 21 CFR 888.3027

FDA Product Code NDN: Cement, Bone, Vertebroplasty

Leading manufacturers include Arthrocare Corp., Tecres S.P.A. and Stryker Corporation.

108
Total
108
Cleared
154d
Avg days
2004
Since
108 devices
73–96 of 108
Cleared Feb 16, 2010
SKELTEX ISV
K091234
Skeltex Technologies, Inc.
Orthopedic · 295d
Cleared Dec 30, 2009
STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)
K090986
Dfine, Inc.
Orthopedic · 267d
Cleared Dec 21, 2009
VERTECEM
K090435
Teknimed, S.A.
Orthopedic · 305d
Cleared Oct 23, 2009
VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
K091606
Stryker Corp.
Orthopedic · 142d
Cleared Jul 01, 2009
INFLATABLE BONE TAMP
K090211
Cardinal Health, Inc.
Orthopedic · 154d
Cleared Jun 05, 2009
CORTOSS BONE AUGMENTATION MATERIAL
K080108
Orthovita, Inc.
Orthopedic · 507d
Cleared Apr 14, 2009
BONOS INJECT
K090460
Aap Biomaterials GmbH
Orthopedic · 50d
Cleared Aug 28, 2008
OPACITY + BONE CEMENT
K080873
Teknimed, S.A.
Orthopedic · 150d
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 21, 2007
MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
K071927
Depuy Spine, A Johnson & Johnson Company
Orthopedic · 132d
Cleared Nov 20, 2007
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
K072133
Cardinal Health, Inc.
Orthopedic · 110d
Cleared Oct 05, 2007
MODIFICATION TO SPACE CPSXL BONE CEMENT
K072496
Dfine, Inc.
Orthopedic · 30d
Cleared Jun 29, 2007
SPACE 360 DELIVERY SYSTEM
K070351
Dfine, Inc.
Orthopedic · 143d
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 Jan 17, 2007
VSPSPN
K063438
Tecres S.P.A.
Orthopedic · 64d
Cleared Nov 03, 2006
CONFIDENCE FENESTRATED INTRODUCER NEEDLE
K063067
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 28d
Cleared Sep 21, 2006
KIT MENDEC SPINE AND DELIVERY SYSTEM
K062452
Tecres S.P.A.
Orthopedic · 30d
Cleared Sep 14, 2006
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
K062424
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 27d
Cleared Aug 30, 2006
SPACE CPSXL BONE CEMENT
K061531
Dfine, Inc.
Orthopedic · 89d
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