ClearanceBrief
Panels › Orthopedic › Product code NDN · Class 2

Cement, Bone, Vertebroplasty

Regulation 888.3027

1510(k)s in 12 months (108 all time)
0recalls in 12 months (86 all time)
51recalls that name a 510(k)
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Top companies in NDN

Company510(k)sRecalls
Zavation, LLC171
Depuy Spine, Inc.28
Stryker Corp.70
Teknimed Sas61
Arthrocare Corp.60
Medtronic50
Tecres S.P.A.50
Dfine, Inc.40
Disc-O-Tech Medical Technologies, Ltd.40
Medtronic Sofamor Danek30
Decided510(k)Device and applicantCode
Dec 14, 2012K100404ASCENDX VCF REDUCTION SYSTEM
Aoi Medical, Inc.
NDN
Oct 23, 2012K122533OSSEOFLEX SB INFLATABLE BONE TAMP
Osseon Therapeutics, Inc.
NDN
Oct 19, 2012K121876VERTECEM II CEMENT KIT
Aap Biomaterials GmbH, DE
NDN
Sep 17, 2012K113742KMC KYPHOPLASTY SYSTEM
Shanghai Kinetic Medical Co., Ltd.
NDN
Feb 17, 2012K113452ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
Ascendx Spine, Inc.
NDN
Jan 24, 2012K113154IVAS BALLOON CATHETER
Stryker Corporation
NDN
Jan 6, 2012K113477IVAS 20MM (10 GAUGE) BALLOON CATHETER
Stryker Instruments, Instruments Div.
NDN
Dec 22, 2011K112907CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
Medos International SARL
NDN
Dec 13, 2011K110604VBB SYSTEM
Synthes
NDN
Dec 8, 2011K093477SHIELD KYPHOPLASTY SYSTEM
Soteira, Inc.
NDN
Nov 18, 2011K111593GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
Bm Korea Co., Ltd.
NDN
Oct 25, 2011K110998AFFIRM (TM) VCF SYSTEM
Algea Therapies
NDN
Jun 28, 2011K103807IVAS 2-10MM (10 GUAGE) BALLON CATHETER
Stryker Corporation
NDN
Feb 28, 2011K102397KYPHON XPEDE BONE CEMENT
Medtronic
NDN
Feb 16, 2011K110183ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
Arthrocare Corp.
NDN
Feb 4, 2011K103816COHESION BONE CEMENT
Teknimed Sas
NDN
Jan 10, 2011K103064AVAMAX VERTEBRAL BALLOON
Care Fusion
NDN
Jan 3, 2011K103433F20
Teknimed, S.A.
NDN
Sep 21, 2010K100479PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
Arthrocare Corp.
NDN
Aug 12, 2010K093828KYPH X HV-R BONE CEMENT
Medtronic, Inc.
NDN
Mar 18, 2010K093419IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS
Stryker Instruments, Instruments Div.
NDN
Feb 26, 2010K093463AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
Care Fusion
NDN
Feb 16, 2010K091234SKELTEX ISV
Skeltex Technologies, Inc., CA
NDN
Dec 30, 2009K090986STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)
Dfine, Inc.
NDN
Dec 21, 2009K090435VERTECEM
Teknimed, S.A.
NDN
Oct 23, 2009K091606VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
Stryker Corp.
NDN
Jul 1, 2009K090211INFLATABLE BONE TAMP
Cardinal Health, Inc.
NDN
Jun 5, 2009K080108CORTOSS BONE AUGMENTATION MATERIAL
Orthovita, Inc.
NDN
Apr 14, 2009K090460BONOS INJECT
Aap Biomaterials GmbH, DE
NDN
Aug 28, 2008K080873OPACITY + BONE CEMENT
Teknimed, S.A.
NDN
Dec 21, 2007K071375MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
Disc-O-Tech Medical Technologies, Ltd.
NDN
Dec 7, 2007K072118STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
Stryker Corp.
NDN
Nov 21, 2007K071927MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
Depuy Spine, A Johnson & Johnson Company
NDN
Nov 20, 2007K072133AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
Cardinal Health, Inc.
NDN
Oct 5, 2007K072496MODIFICATION TO SPACE CPSXL BONE CEMENT
Dfine, Inc.
NDN
Jun 29, 2007K070351SPACE 360 DELIVERY SYSTEM
Dfine, Inc.
NDN
May 4, 2007K070527ARCUATE VERTEBRAL AUGMENTATION SYSTEM
Medtronic Sofamor Danek
NDN
Mar 13, 2007K063248ARCUATE VERTEBRAL AUGMENTATION SYSTEM
Medtronic Sofamor Danek
NDN
Jan 17, 2007K063438VSPSPN
Tecres S.P.A.
NDN
Nov 3, 2006K063067CONFIDENCE FENESTRATED INTRODUCER NEEDLE
Disc-O-Tech Medical Technologies, Ltd.
NDN
Sep 21, 2006K062452KIT MENDEC SPINE AND DELIVERY SYSTEM
Tecres S.P.A.
NDN
Sep 14, 2006K062424CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
Disc-O-Tech Medical Technologies, Ltd.
NDN
Aug 30, 2006K061531SPACE CPSXL BONE CEMENT
Dfine, Inc.
NDN
Jul 12, 2006K060425PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
Arthrocare Corp.
NDN
Jul 3, 2006K053336STAXX FX SYSTEM
Spine Wave, Inc.
NDN
Jun 21, 2006K060300CONFIDENCE HIGH VISCOSITY BONE CEMENT
Disc-O-Tech Medical Technologies, Ltd., IL
NDN
Mar 17, 2006K043593SPINE-FIX BIOMIMETIC BONE CEMENT
Teknimed, S.A.
NDN
Mar 13, 2006K060148EBI VERTEBROPLASTY SYSTEMS
Ebi, L.P.
NDN
Jan 25, 2006K053180PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
Arthrocare Corp.
NDN
Nov 8, 2005K042691VERTEFIX VERTEBROPLASTY PROCEDURE SET
Cook, Inc.
NDN

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