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
25–48 of 108
Cleared Feb 06, 2017
DCM Kyphoplasty System
K162283
Dragon Crown Medical Co., Ltd.
Orthopedic · 175d
Cleared Jan 23, 2017
CONCORD Plus Radiopaque Bone Cement
K162618
Globus Medical, Inc.
Orthopedic · 125d
Cleared Nov 01, 2016
13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
K162453
Pan Medical , Ltd.
Orthopedic · 61d
Cleared Aug 24, 2016
Kyphon HV-R Bone Cement
K160983
Medtronic, Inc.
Orthopedic · 139d
Cleared Jul 29, 2016
MEDINAUT Kyphoplasty System
K153296
Imedicom Co., Ltd.
Orthopedic · 259d
Cleared Feb 23, 2016
Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
K152557
G21, S.R.L.
Orthopedic · 168d
Cleared Nov 16, 2015
KYPHON XPEDE Bone Cement
K151227
Medtronic
Orthopedic · 193d
Cleared Jun 12, 2015
Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
K150582
Stryker Corporation
Orthopedic · 95d
Cleared Apr 28, 2015
KYPHON (R) HV-R(R) Bone Cement
K150460
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 64d
Cleared Apr 09, 2015
Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
K150607
Osseon, LLC
Orthopedic · 30d
Cleared Mar 06, 2015
InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)
K150322
Pan Medical , Ltd.
Orthopedic · 25d
Cleared Jan 16, 2015
GUARDIAN-SG Inflatable Bone Expander System
K143006
Bm Korea Co., Ltd.
Orthopedic · 88d
Cleared Sep 12, 2014
ZVPLASTY
K141419
Zavation, LLC
Orthopedic · 106d
Cleared Aug 21, 2014
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
K141930
Osseon, LLC
Orthopedic · 36d
Cleared Aug 14, 2014
KIVA VCF TREATMENT SYSTEM
K141141
Benvenue Medical, Inc.
Orthopedic · 104d
Cleared Jun 19, 2014
OSSEOFLEX SB
K140937
Osseon, LLC
Orthopedic · 69d
Cleared Apr 16, 2014
INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
K132620
Pan Medical , Ltd.
Orthopedic · 238d
Cleared Apr 04, 2014
MEDINAUT KYPHOPLASTY SYSTEM
K133669
Imedicom
Orthopedic · 126d
Cleared Jan 24, 2014
KIVA VCF TREATMENT SYSTEM
K132817
Benvenue Medical, Inc.
Orthopedic · 137d
Cleared Dec 06, 2013
CROSSTREES PVA POD
K133372
Crosstrees Medical, Inc.
Orthopedic · 35d
Cleared Aug 09, 2013
CROSSTREES PVA POD
K130089
Crosstrees Medical, Inc.
Orthopedic · 207d
Cleared Jun 25, 2013
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
K122503
Neuro Therm, Inc.
Orthopedic · 313d
Cleared May 20, 2013
SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
K130146
Synthes (Usa), LLC
Orthopedic · 118d
Cleared Apr 03, 2013
STRYKER IVAS BALLOON CATHETER
K123942
Stryker Corporation
Orthopedic · 104d