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
49–72 of 108
Cleared Apr 01, 2013
SPIDER SYSTEM KOLIBRI CEMENT NEEDLE
K130402
Sintea Plustek, LLC
Orthopedic · 41d
Cleared Mar 28, 2013
MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
K122175
Tecres S.P.A.
Orthopedic · 248d
Cleared Oct 23, 2012
OSSEOFLEX SB INFLATABLE BONE TAMP
K122533
Osseon Therapeutics, Inc.
Orthopedic · 64d
Cleared Oct 19, 2012
VERTECEM II CEMENT KIT
K121876
Aap Biomaterials GmbH
Orthopedic · 114d
Cleared Sep 17, 2012
KMC KYPHOPLASTY SYSTEM
K113742
Shanghai Kinetic Medical Co., Ltd.
Orthopedic · 272d
Cleared Feb 17, 2012
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
K113452
Ascendx Spine, Inc.
Orthopedic · 88d
Cleared Jan 24, 2012
IVAS BALLOON CATHETER
K113154
Stryker Corporation
Orthopedic · 90d
Cleared Jan 06, 2012
IVAS 20MM (10 GAUGE) BALLOON CATHETER
K113477
Stryker Instruments, Instruments Div.
Orthopedic · 44d
Cleared Dec 22, 2011
CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
K112907
Medos International SARL
Orthopedic · 80d
Cleared Dec 13, 2011
VBB SYSTEM
K110604
Synthes
Orthopedic · 285d
Cleared Nov 18, 2011
GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
K111593
Bm Korea Co., Ltd.
Orthopedic · 164d
Cleared Oct 25, 2011
AFFIRM (TM) VCF SYSTEM
K110998
Algea Therapies
Orthopedic · 197d
Cleared Jun 28, 2011
IVAS 2-10MM (10 GUAGE) BALLON CATHETER
K103807
Stryker Corporation
Orthopedic · 181d
Cleared Feb 28, 2011
KYPHON XPEDE BONE CEMENT
K102397
Medtronic
Orthopedic · 188d
Cleared Feb 16, 2011
ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K110183
Arthrocare Corp.
Orthopedic · 26d
Cleared Feb 04, 2011
COHESION BONE CEMENT
K103816
Teknimed Sas
Orthopedic · 37d
Cleared Jan 10, 2011
AVAMAX VERTEBRAL BALLOON
K103064
Care Fusion
Orthopedic · 84d
Cleared Jan 03, 2011
F20
K103433
Teknimed, S.A.
Orthopedic · 40d
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 Feb 26, 2010
AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
K093463
Care Fusion
Orthopedic · 112d
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