FDA Product Code
FDA Product Code NDN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3027
510(k) Clearances — 108 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251896 | XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed , Ltd. | 2026-01-28 | Traditional | PDF ↗ |
| K250637 | VCFix Spinal System | Amber Implants | 2025-05-30 | Traditional | PDF ↗ |
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement System | Xelite Biomed , Ltd. | 2025-04-11 | Traditional | PDF ↗ |
| K241775 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement | Xelite Biomed , Ltd. | 2024-09-18 | Traditional | PDF ↗ |
| K232842 | Balloon Inflation System | Ningbo Hicren Biotechnology Co., Ltd. | 2024-02-29 | Traditional | PDF ↗ |
| K240084 | V-STRUT® Vertebral Implant | Hyprevention | 2024-02-09 | Special | PDF ↗ |
| K231340 | Renova Spine Balloon Catheter | Biopsybell S.R.L. | 2023-10-30 | Traditional | PDF ↗ |
| K221697 | INJECTION PIN (KIP(02031-02061) (03031-03061)) | Slk Ortho, LLC | 2023-03-03 | Traditional | PDF ↗ |
| K223294 | SpineJack® Expansion Kit | Stryker Instruments | 2022-12-20 | Traditional | PDF ↗ |
| K220131 | KYPHON VuE Bone Cement | Tecres S.P.A. | 2022-04-18 | Traditional | PDF ↗ |
| K211797 | TRACKER Plus Kyphoplasty System | GS Medical Co., Ltd. | 2021-10-28 | Traditional | PDF ↗ |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement | Stryker Instruments | 2021-06-25 | Traditional | PDF ↗ |
| K202393 | SpineJack Expansion Kit | Stryker Corporation | 2020-10-20 | Traditional | PDF ↗ |
| K201831 | CONFIDENCE Spinal Cement System | Depuy Spine, Inc. | 2020-08-31 | Traditional | PDF ↗ |
| K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | 2020-05-27 | Traditional | PDF ↗ |
| K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | 2020-03-05 | Traditional | PDF ↗ |
| K192335 | TRACKER Kyphoplasty System | GS Medical Co., Ltd. | 2019-12-04 | Traditional | PDF ↗ |
| K192403 | VK100 Percutaneous Vertebral Augmentation System | Bonwrx, Ltd. | 2019-11-08 | Traditional | PDF ↗ |
| K181262 | SpineJack Expansion Kit | Vexim SA | 2018-08-30 | Traditional | PDF ↗ |
| K172871 | SpineKure Kyphoplasty System | Hanchang Co., Ltd. | 2018-05-29 | Traditional | PDF ↗ |
| K180700 | KYPHON HV-R Bone Cement | Medtronic Sofamor Danek USA, Inc. | 2018-05-18 | Traditional | PDF ↗ |
| K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G-21 S.R.L. | 2017-08-23 | Special | PDF ↗ |
| K161114 | HIGH V+ | Teknimed Sas | 2017-04-12 | Traditional | PDF ↗ |
| K163032 | Kyphon Xpede Bone Cement | Medtronic, Inc. | 2017-02-27 | Traditional | PDF ↗ |
| K162283 | DCM Kyphoplasty System | Dragon Crown Medical Co., Ltd. | 2017-02-06 | Traditional | PDF ↗ |
| K162618 | CONCORD Plus Radiopaque Bone Cement | Globus Medical, Inc. | 2017-01-23 | Traditional | PDF ↗ |
| K162453 | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) | Pan Medical , Ltd. | 2016-11-01 | Special | PDF ↗ |
| K160983 | Kyphon HV-R Bone Cement | Medtronic, Inc. | 2016-08-24 | Traditional | PDF ↗ |
| K153296 | MEDINAUT Kyphoplasty System | Imedicom Co., Ltd. | 2016-07-29 | Traditional | PDF ↗ |
| K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters | G21, S.R.L. | 2016-02-23 | Traditional | PDF ↗ |
| K151227 | KYPHON XPEDE Bone Cement | Medtronic | 2015-11-16 | Traditional | PDF ↗ |
| K150582 | Vertaplex® High Viscosity (HV) Radiopaque Bone Cement | Stryker Corporation | 2015-06-12 | Traditional | PDF ↗ |
| K150460 | KYPHON (R) HV-R(R) Bone Cement | Medtronic Sofamor Danck USA, Inc. | 2015-04-28 | Traditional | PDF ↗ |
| K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml | Osseon, LLC | 2015-04-09 | Special | PDF ↗ |
| K150322 | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) | Pan Medical , Ltd. | 2015-03-06 | Special | PDF ↗ |
| K143006 | GUARDIAN-SG Inflatable Bone Expander System | Bm Korea Co., Ltd. | 2015-01-16 | Traditional | PDF ↗ |
| K141419 | ZVPLASTY | Zavation, LLC | 2014-09-12 | Traditional | PDF ↗ |
| K141930 | OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML | Osseon, LLC | 2014-08-21 | Special | PDF ↗ |
| K141141 | KIVA VCF TREATMENT SYSTEM | Benvenue Medical, Inc. | 2014-08-14 | Traditional | PDF ↗ |
| K140937 | OSSEOFLEX SB | Osseon, LLC | 2014-06-19 | Special | PDF ↗ |
| K132620 | INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL | Pan Medical , Ltd. | 2014-04-16 | Traditional | PDF ↗ |
| K133669 | MEDINAUT KYPHOPLASTY SYSTEM | Imedicom | 2014-04-04 | Traditional | PDF ↗ |
| K132817 | KIVA VCF TREATMENT SYSTEM | Benvenue Medical, Inc. | 2014-01-24 | Traditional | PDF ↗ |
| K133372 | CROSSTREES PVA POD | Crosstrees Medical, Inc. | 2013-12-06 | Special | PDF ↗ |
| K130089 | CROSSTREES PVA POD | Crosstrees Medical, Inc. | 2013-08-09 | Traditional | PDF ↗ |
| K122503 | PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON | Neuro Therm, Inc. | 2013-06-25 | Traditional | PDF ↗ |
| K130146 | SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM | Synthes (Usa), LLC | 2013-05-20 | Traditional | PDF ↗ |
| K123942 | STRYKER IVAS BALLOON CATHETER | Stryker Corporation | 2013-04-03 | Traditional | PDF ↗ |
| K130402 | SPIDER SYSTEM KOLIBRI CEMENT NEEDLE | Sintea Plustek, LLC | 2013-04-01 | Special | PDF ↗ |
| K122175 | MENDEC SPINE HV, MENDEC SPINE HV SYSTEM | Tecres S.P.A. | 2013-03-28 | Traditional | PDF ↗ |
| K100404 | ASCENDX VCF REDUCTION SYSTEM | Aoi Medical, Inc. | 2012-12-14 | Traditional | PDF ↗ |
| K122533 | OSSEOFLEX SB INFLATABLE BONE TAMP | Osseon Therapeutics, Inc. | 2012-10-23 | Traditional | PDF ↗ |
| K121876 | VERTECEM II CEMENT KIT | Aap Biomaterials GmbH | 2012-10-19 | Abbreviated | PDF ↗ |
| K113742 | KMC KYPHOPLASTY SYSTEM | Shanghai Kinetic Medical Co., Ltd. | 2012-09-17 | Traditional | PDF ↗ |
| K113452 | ACU-CUT VERTEBRAL AUGMENTATION SYSTEM | Ascendx Spine, Inc. | 2012-02-17 | Traditional | PDF ↗ |
| K113154 | IVAS BALLOON CATHETER | Stryker Corporation | 2012-01-24 | Traditional | PDF ↗ |
| K113477 | IVAS 20MM (10 GAUGE) BALLOON CATHETER | Stryker Instruments, Instruments Div. | 2012-01-06 | Traditional | PDF ↗ |
| K112907 | CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G | Medos International SARL | 2011-12-22 | Traditional | PDF ↗ |
| K110604 | VBB SYSTEM | Synthes | 2011-12-13 | Traditional | PDF ↗ |
| K093477 | SHIELD KYPHOPLASTY SYSTEM | Soteira, Inc. | 2011-12-08 | Traditional | PDF ↗ |
| K111593 | GUARDIAN INFLATABLE BONE EXPANDER SYSTEM | Bm Korea Co., Ltd. | 2011-11-18 | Traditional | PDF ↗ |
| K110998 | AFFIRM (TM) VCF SYSTEM | Algea Therapies | 2011-10-25 | Traditional | PDF ↗ |
| K103807 | IVAS 2-10MM (10 GUAGE) BALLON CATHETER | Stryker Corporation | 2011-06-28 | Traditional | PDF ↗ |
| K102397 | KYPHON XPEDE BONE CEMENT | Medtronic | 2011-02-28 | Traditional | PDF ↗ |
| K110183 | ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | Arthrocare Corp. | 2011-02-16 | Special | PDF ↗ |
| K103816 | COHESION BONE CEMENT | Teknimed Sas | 2011-02-04 | Special | PDF ↗ |
| K103064 | AVAMAX VERTEBRAL BALLOON | Care Fusion | 2011-01-10 | Traditional | PDF ↗ |
| K103433 | F20 | Teknimed, S.A. | 2011-01-03 | Special | PDF ↗ |
| K100479 | PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | Arthrocare Corp. | 2010-09-21 | Traditional | PDF ↗ |
| K093828 | KYPH X HV-R BONE CEMENT | Medtronic, Inc. | 2010-08-12 | Special | PDF ↗ |
| K093419 | IVAS 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. | 2010-03-18 | Traditional | PDF ↗ |
| K093463 | AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 | Care Fusion | 2010-02-26 | Traditional | PDF ↗ |
| K091234 | SKELTEX ISV | Skeltex Technologies, Inc. | 2010-02-16 | Traditional | PDF ↗ |
| K090986 | STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) | Dfine, Inc. | 2009-12-30 | Traditional | PDF ↗ |
| K090435 | VERTECEM | Teknimed, S.A. | 2009-12-21 | Special | PDF ↗ |
| K091606 | VERTAPLEX HV (SINGLE PACK AND DUAL PACK) | Stryker Corp. | 2009-10-23 | Traditional | PDF ↗ |
| K090211 | INFLATABLE BONE TAMP | Cardinal Health, Inc. | 2009-07-01 | Traditional | PDF ↗ |
| K080108 | CORTOSS BONE AUGMENTATION MATERIAL | Orthovita, Inc. | 2009-06-05 | Traditional | PDF ↗ |
| K090460 | BONOS INJECT | Aap Biomaterials GmbH | 2009-04-14 | Abbreviated | PDF ↗ |
| K080873 | OPACITY + BONE CEMENT | Teknimed, S.A. | 2008-08-28 | Special | PDF ↗ |
| K071375 | MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) | Disc-O-Tech Medical Technologies, Ltd. | 2007-12-21 | Traditional | PDF ↗ |
| K072118 | STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT | Stryker Corp. | 2007-12-07 | Traditional | PDF ↗ |
| K071927 | MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT | Depuy Spine, A Johnson & Johnson Company | 2007-11-21 | Special | PDF ↗ |
| K072133 | AVAFLEX VERTEBRAL AUGMENTATION NEEDLE | Cardinal Health, Inc. | 2007-11-20 | Traditional | PDF ↗ |
| K072496 | MODIFICATION TO SPACE CPSXL BONE CEMENT | Dfine, Inc. | 2007-10-05 | Special | PDF ↗ |
| K070351 | SPACE 360 DELIVERY SYSTEM | Dfine, Inc. | 2007-06-29 | Traditional | PDF ↗ |
| K070527 | ARCUATE VERTEBRAL AUGMENTATION SYSTEM | Medtronic Sofamor Danek | 2007-05-04 | Traditional | PDF ↗ |
| K063248 | ARCUATE VERTEBRAL AUGMENTATION SYSTEM | Medtronic Sofamor Danek | 2007-03-13 | Traditional | PDF ↗ |
| K063438 | VSPSPN | Tecres S.P.A. | 2007-01-17 | Traditional | PDF ↗ |
| K063067 | CONFIDENCE FENESTRATED INTRODUCER NEEDLE | Disc-O-Tech Medical Technologies, Ltd. | 2006-11-03 | Special | PDF ↗ |
| K062452 | KIT MENDEC SPINE AND DELIVERY SYSTEM | Tecres S.P.A. | 2006-09-21 | Special | PDF ↗ |
| K062424 | CONFIDENCE EX HIGH VISCOSITY BONE CEMENT | Disc-O-Tech Medical Technologies, Ltd. | 2006-09-14 | Special | PDF ↗ |
| K061531 | SPACE CPSXL BONE CEMENT | Dfine, Inc. | 2006-08-30 | Traditional | PDF ↗ |
| K060425 | PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA | Arthrocare Corp. | 2006-07-12 | Traditional | PDF ↗ |
| K053336 | STAXX FX SYSTEM | Spine Wave, Inc. | 2006-07-03 | Traditional | PDF ↗ |
| K060300 | CONFIDENCE HIGH VISCOSITY BONE CEMENT | Disc-O-Tech Medical Technologies, Ltd. | 2006-06-21 | Traditional | PDF ↗ |
| K043593 | SPINE-FIX BIOMIMETIC BONE CEMENT | Teknimed, S.A. | 2006-03-17 | Traditional | PDF ↗ |
| K060148 | EBI VERTEBROPLASTY SYSTEMS | Ebi, L.P. | 2006-03-13 | Traditional | PDF ↗ |
| K053180 | PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS | Arthrocare Corp. | 2006-01-25 | Traditional | PDF ↗ |
| K042691 | VERTEFIX VERTEBROPLASTY PROCEDURE SET | Cook, Inc. | 2005-11-08 | Traditional | PDF ↗ |
Product code NDN · Class II · Orthopedic. Data: openFDA.