FDA 510(k) Applications for Medical Device Product Code "NDN"
(Cement, Bone, Vertebroplasty)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K090460 | AAP BIOMATERIALS GMBH | BONOS INJECT | 04/14/2009 |
| K121876 | AAP BIOMATERIALS GMBH | VERTECEM II CEMENT KIT | 10/19/2012 |
| K110998 | ALGEA THERAPIES | AFFIRM (TM) VCF SYSTEM | 10/25/2011 |
| K100404 | AOI MEDICAL, INC. | ASCENDX VCF REDUCTION SYSTEM | 12/14/2012 |
| K110183 | ARTHROCARE CORP. | ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | 02/16/2011 |
| K053180 | ARTHROCARE CORP. | PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS | 01/25/2006 |
| K060425 | ARTHROCARE CORP. | PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA | 07/12/2006 |
| K050864 | ARTHROCARE CORP. | PARALLAX ACRYLIC RESIN WITH TRACERS TA | 06/17/2005 |
| K042947 | ARTHROCARE CORP. | PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 | 12/27/2004 |
| K100479 | ARTHROCARE CORP. | PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | 09/21/2010 |
| K113452 | ASCENDX SPINE, INC. | ACU-CUT VERTEBRAL AUGMENTATION SYSTEM | 02/17/2012 |
| K132817 | BENVENUE MEDICAL, INC. | KIVA VCF TREATMENT SYSTEM | 01/24/2014 |
| K141141 | BENVENUE MEDICAL, INC. | KIVA VCF TREATMENT SYSTEM | 08/14/2014 |
| K111593 | BM KOREA CO., LTD. | GUARDIAN INFLATABLE BONE EXPANDER SYSTEM | 11/18/2011 |
| K143006 | BM KOREA CO., LTD. | GUARDIAN-SG Inflatable Bone Expander System | 01/16/2015 |
| K192403 | BONWRx Ltd | VK100 Percutaneous Vertebral Augmentation System | 11/08/2019 |
| K043518 | Cardinal Health | RADIOPAQUE BONE CEMENT | 05/11/2005 |
| K072133 | CARDINAL HEALTH, INC. | AVAFLEX VERTEBRAL AUGMENTATION NEEDLE | 11/20/2007 |
| K090211 | CARDINAL HEALTH, INC. | INFLATABLE BONE TAMP | 07/01/2009 |
| K103064 | CAREFUSION | AVAMAX VERTEBRAL BALLOON | 01/10/2011 |
| K093463 | CAREFUSION | AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 | 02/26/2010 |
| K042691 | COOK, INC. | VERTEFIX VERTEBROPLASTY PROCEDURE SET | 11/08/2005 |
| K133372 | CROSSTREES MEDICAL, INC. | CROSSTREES PVA POD | 12/06/2013 |
| K130089 | CROSSTREES MEDICAL, INC. | CROSSTREES PVA POD | 08/09/2013 |
| K071927 | DEPUY SPINE, A JOHNSON & JOHNSON COMPANY | MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT | 11/21/2007 |
| K201831 | DePuy Spine, Inc. | CONFIDENCE Spinal Cement System | 08/31/2020 |
| K043406 | DEPUY SPINE,INC | VERTEBROPLASTIC RADIOPAQUE BONE CEMENT | 07/15/2005 |
| K072496 | DFINE, INC. | MODIFICATION TO SPACE CPSXL BONE CEMENT | 10/05/2007 |
| K070351 | DFINE, INC. | SPACE 360 DELIVERY SYSTEM | 06/29/2007 |
| K061531 | DFINE, INC. | SPACE CPSXL BONE CEMENT | 08/30/2006 |
| K090986 | DFINE, INC. | STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) | 12/30/2009 |
| K062424 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. | CONFIDENCE EX HIGH VISCOSITY BONE CEMENT | 09/14/2006 |
| K063067 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. | CONFIDENCE FENESTRATED INTRODUCER NEEDLE | 11/03/2006 |
| K060300 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. | CONFIDENCE HIGH VISCOSITY BONE CEMENT | 06/21/2006 |
| K071375 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. | MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) | 12/21/2007 |
| K162283 | Dragon Crown Medical Co., Ltd. | DCM Kyphoplasty System | 02/06/2017 |
| K060148 | EBI, L.P. | EBI VERTEBROPLASTY SYSTEMS | 03/13/2006 |
| K172214 | G-21 s.r.l. | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | 08/23/2017 |
| K152557 | G21 s.r.l. | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters | 02/23/2016 |
| K042168 | Globus Medical, Inc | CONCORD Radiopaque Bone Cement | 01/14/2005 |
| K162618 | GLOBUS MEDICAL, INC. | CONCORD Plus Radiopaque Bone Cement | 01/23/2017 |
| K211797 | GS Medical Co. Ltd. | TRACKER Plus Kyphoplasty System | 10/28/2021 |
| K192335 | GS Medical Co., Ltd. | TRACKER Kyphoplasty System | 12/04/2019 |
| K172871 | Hanchang Co., Ltd. | SpineKure Kyphoplasty System | 05/29/2018 |
| K191709 | Hyprevention SAS | V-STRUT Vertebral Implant | 03/05/2020 |
| K133669 | IMEDICOM | MEDINAUT KYPHOPLASTY SYSTEM | 04/04/2014 |
| K153296 | IMEDICOM Co., Ltd. | MEDINAUT Kyphoplasty System | 07/29/2016 |
| K192449 | Joline GmbH & Co. KG | Joline Kyphoplasty System Allevo | 05/27/2020 |
| K041584 | KYPHON, INC. | KYPHX HV-R BONE CEMENT, MODEL C01A | 07/07/2004 |
| K033801 | KYPHON, INC. | KYPHX HV-R, MODEL C01A | 04/01/2004 |
| K112907 | MEDOS INTERNATIONAL SARL | CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G | 12/22/2011 |
| K102397 | Medtronic | KYPHON XPEDE BONE CEMENT | 02/28/2011 |
| K151227 | MEDTRONIC | KYPHON XPEDE Bone Cement | 11/16/2015 |
| K160983 | MEDTRONIC INC | Kyphon HV-R Bone Cement | 08/24/2016 |
| K093828 | MEDTRONIC INC. | KYPH X HV-R BONE CEMENT | 08/12/2010 |
| K163032 | Medtronic Inc. | Kyphon Xpede Bone Cement | 02/27/2017 |
| K150460 | MEDTRONIC SOFAMOR DANCK USA, INC. | KYPHON (R) HV-R(R) Bone Cement | 04/28/2015 |
| K063248 | MEDTRONIC SOFAMOR DANEK | ARCUATE VERTEBRAL AUGMENTATION SYSTEM | 03/13/2007 |
| K070527 | MEDTRONIC SOFAMOR DANEK | ARCUATE VERTEBRAL AUGMENTATION SYSTEM | 05/04/2007 |
| K180700 | Medtronic Sofamor Danek USA, Inc. | KYPHON HV-R Bone Cement | 05/18/2018 |
| K122503 | NEURO THERM, INC. | PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON | 06/25/2013 |
| K080108 | ORTHOVITA, INC. | CORTOSS BONE AUGMENTATION MATERIAL | 06/05/2009 |
| K140937 | OSSEON LLC | OSSEOFLEX SB | 06/19/2014 |
| K150607 | OSSEON LLC | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml | 04/09/2015 |
| K141930 | OSSEON LLC | OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML | 08/21/2014 |
| K122533 | OSSEON THERAPEUTICS, INC. | OSSEOFLEX SB INFLATABLE BONE TAMP | 10/23/2012 |
| K132620 | PAN MEDICAL LTD | INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL | 04/16/2014 |
| K150322 | PAN MEDICAL LTD | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) | 03/06/2015 |
| K162453 | Pan Medical Ltd. | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) | 11/01/2016 |
| K113742 | SHANGHAI KINETIC MEDICAL CO., LTD | KMC KYPHOPLASTY SYSTEM | 09/17/2012 |
| K130402 | SINTEA PLUSTEK, LLC | SPIDER SYSTEM KOLIBRI CEMENT NEEDLE | 04/01/2013 |
| K091234 | SKELTEX TECHNOLOGIES, INC. | SKELTEX ISV | 02/16/2010 |
| K221697 | SLK Ortho Llc | INJECTION PIN (KIP(02031-02061) (03031-03061)) | 03/03/2023 |
| K093477 | SOTEIRA, INC. | SHIELD KYPHOPLASTY SYSTEM | 12/08/2011 |
| K053336 | SPINE WAVE, INC. | STAXX FX SYSTEM | 07/03/2006 |
| K072118 | STRYKER CORP. | STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT | 12/07/2007 |
| K091606 | STRYKER CORP. | VERTAPLEX HV (SINGLE PACK AND DUAL PACK) | 10/23/2009 |
| K103807 | STRYKER CORPORATION | IVAS 2-10MM (10 GUAGE) BALLON CATHETER | 06/28/2011 |
| K113154 | STRYKER CORPORATION | IVAS BALLOON CATHETER | 01/24/2012 |
| K202393 | Stryker Corporation | SpineJack Expansion Kit | 10/20/2020 |
| K123942 | STRYKER CORPORATION | STRYKER IVAS BALLOON CATHETER | 04/03/2013 |
| K150582 | STRYKER CORPORATION | Vertaplex« High Viscosity (HV) Radiopaque Bone Cement | 06/12/2015 |
| K211238 | Stryker Instruments | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement | 06/25/2021 |
| K223294 | Stryker Instruments | SpineJack« Expansion Kit | 12/20/2022 |
| K093419 | STRYKER INSTRUMENTS, INSTRUMENTS DIV. | IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS | 03/18/2010 |
| K113477 | STRYKER INSTRUMENTS, INSTRUMENTS DIV. | IVAS 20MM (10 GAUGE) BALLOON CATHETER | 01/06/2012 |
| K110604 | SYNTHES | VBB SYSTEM | 12/13/2011 |
| K130146 | SYNTHES (USA) LLC | SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM | 05/20/2013 |
| K220131 | Tecres S.p.A. | KYPHON VuE Bone Cement | 04/18/2022 |
| K062452 | TECRES SPA | KIT MENDEC SPINE AND DELIVERY SYSTEM | 09/21/2006 |
| K042415 | TECRES SPA | MENDEC SPINE | 06/09/2005 |
| K122175 | TECRES SPA | MENDEC SPINE HV, MENDEC SPINE HV SYSTEM | 03/28/2013 |
| K063438 | TECRES SPA | VSPSPN | 01/17/2007 |
| K103433 | TEKNIMED SA | F20 | 01/03/2011 |
| K080873 | TEKNIMED SA | OPACITY + BONE CEMENT | 08/28/2008 |
| K043593 | TEKNIMED SA | SPINE-FIX BIOMIMETIC BONE CEMENT | 03/17/2006 |
| K090435 | TEKNIMED SA | VERTECEM | 12/21/2009 |
| K103816 | TEKNIMED, S.A.S. | COHESION BONE CEMENT | 02/04/2011 |
| K161114 | Teknimed, SAS | HIGH V+ | 04/12/2017 |
| K181262 | Vexim SA | SpineJack Expansion Kit | 08/30/2018 |
| K141419 | ZAVATION LLC | ZVPLASTY | 09/12/2014 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
