NDN · Class II · 21 CFR 888.3027

FDA Product Code NDN: Cement, Bone, Vertebroplasty

Leading manufacturers include Arthrocare Corp., Stryker Corporation and Xelite Biomed , Ltd..

108
Total
108
Cleared
154d
Avg days
2004
Since
108 devices
25–48 of 108
Cleared Jun 12, 2015
Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
K150582
Stryker Corporation
Orthopedic · 95d
Cleared Apr 03, 2013
STRYKER IVAS BALLOON CATHETER
K123942
Stryker Corporation
Orthopedic · 104d
Cleared Jan 24, 2012
IVAS BALLOON CATHETER
K113154
Stryker Corporation
Orthopedic · 90d
Cleared Dec 22, 2011
CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
K112907
Medos International SARL
Orthopedic · 80d
Cleared Jun 28, 2011
IVAS 2-10MM (10 GUAGE) BALLON CATHETER
K103807
Stryker Corporation
Orthopedic · 181d
Cleared Feb 16, 2011
ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K110183
Arthrocare Corp.
Orthopedic · 26d
Cleared Sep 21, 2010
PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K100479
Arthrocare Corp.
Orthopedic · 215d
Cleared Aug 12, 2010
KYPH X HV-R BONE CEMENT
K093828
Medtronic, Inc.
Orthopedic · 241d
Cleared Oct 23, 2009
VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
K091606
Stryker Corp.
Orthopedic · 142d
Cleared Dec 07, 2007
STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
K072118
Stryker Corp.
Orthopedic · 128d
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 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 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 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