| XeliteMed SuperM-Fix Spinal Bone Cement (K251896) | Xelite Biomed , Ltd. | 2026-01-28 |
| VCFix Spinal System (K250637) | Amber Implants | 2025-05-30 |
| XeliteMed VertehighFix High Viscosity Spinal Bone Cement System (K243537) | Xelite Biomed , Ltd. | 2025-04-11 |
| XeliteMed VertehighFix High Viscosity Spinal Bone Cement (K241775) | Xelite Biomed , Ltd. | 2024-09-18 |
| Balloon Inflation System (K232842) | Ningbo Hicren Biotechnology Co., Ltd. | 2024-02-29 |
| V-STRUT® Vertebral Implant (K240084) | Hyprevention | 2024-02-09 |
| Renova Spine Balloon Catheter (K231340) | Biopsybell S.R.L. | 2023-10-30 |
| INJECTION PIN (KIP(02031-02061) (03031-03061)) (K221697) | Slk Ortho, LLC | 2023-03-03 |
| SpineJack® Expansion Kit (K223294) | Stryker Instruments | 2022-12-20 |
| KYPHON VuE Bone Cement (K220131) | Tecres S.P.A. | 2022-04-18 |
| TRACKER Plus Kyphoplasty System (K211797) | GS Medical Co., Ltd. | 2021-10-28 |
| SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement (K211238) | Stryker Instruments | 2021-06-25 |
| SpineJack Expansion Kit (K202393) | Stryker Corporation | 2020-10-20 |
| CONFIDENCE Spinal Cement System (K201831) | Depuy Spine, Inc. | 2020-08-31 |
| Joline Kyphoplasty System Allevo (K192449) | Joline GmbH & Co. KG | 2020-05-27 |
| V-STRUT Vertebral Implant (K191709) | Hyprevention Sas | 2020-03-05 |
| TRACKER Kyphoplasty System (K192335) | GS Medical Co., Ltd. | 2019-12-04 |
| VK100 Percutaneous Vertebral Augmentation System (K192403) | Bonwrx, Ltd. | 2019-11-08 |
| SpineJack Expansion Kit (K181262) | Vexim SA | 2018-08-30 |
| SpineKure Kyphoplasty System (K172871) | Hanchang Co., Ltd. | 2018-05-29 |
| KYPHON HV-R Bone Cement (K180700) | Medtronic Sofamor Danek USA, Inc. | 2018-05-18 |
| Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters (K172214) | G-21 S.R.L. | 2017-08-23 |
| HIGH V+ (K161114) | Teknimed Sas | 2017-04-12 |
| Kyphon Xpede Bone Cement (K163032) | Medtronic, Inc. | 2017-02-27 |
| DCM Kyphoplasty System (K162283) | Dragon Crown Medical Co., Ltd. | 2017-02-06 |
| CONCORD Plus Radiopaque Bone Cement (K162618) | Globus Medical, Inc. | 2017-01-23 |
| 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) (K162453) | Pan Medical , Ltd. | 2016-11-01 |
| Kyphon HV-R Bone Cement (K160983) | Medtronic, Inc. | 2016-08-24 |
| MEDINAUT Kyphoplasty System (K153296) | Imedicom Co., Ltd. | 2016-07-29 |
| Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters (K152557) | G21, S.R.L. | 2016-02-23 |
| KYPHON XPEDE Bone Cement (K151227) | Medtronic | 2015-11-16 |
| Vertaplex® High Viscosity (HV) Radiopaque Bone Cement (K150582) | Stryker Corporation | 2015-06-12 |
| KYPHON (R) HV-R(R) Bone Cement (K150460) | Medtronic Sofamor Danck USA, Inc. | 2015-04-28 |
| Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml (K150607) | Osseon, LLC | 2015-04-09 |
| InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) (K150322) | Pan Medical , Ltd. | 2015-03-06 |
| GUARDIAN-SG Inflatable Bone Expander System (K143006) | Bm Korea Co., Ltd. | 2015-01-16 |
| ZVPLASTY (K141419) | Zavation, LLC | 2014-09-12 |
| OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML (K141930) | Osseon, LLC | 2014-08-21 |
| KIVA VCF TREATMENT SYSTEM (K141141) | Benvenue Medical, Inc. | 2014-08-14 |
| OSSEOFLEX SB (K140937) | Osseon, LLC | 2014-06-19 |
| INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL (K132620) | Pan Medical , Ltd. | 2014-04-16 |
| MEDINAUT KYPHOPLASTY SYSTEM (K133669) | Imedicom | 2014-04-04 |
| KIVA VCF TREATMENT SYSTEM (K132817) | Benvenue Medical, Inc. | 2014-01-24 |
| CROSSTREES PVA POD (K133372) | Crosstrees Medical, Inc. | 2013-12-06 |
| CROSSTREES PVA POD (K130089) | Crosstrees Medical, Inc. | 2013-08-09 |
| PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON (K122503) | Neuro Therm, Inc. | 2013-06-25 |
| SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM (K130146) | Synthes (Usa), LLC | 2013-05-20 |
| STRYKER IVAS BALLOON CATHETER (K123942) | Stryker Corporation | 2013-04-03 |
| SPIDER SYSTEM KOLIBRI CEMENT NEEDLE (K130402) | Sintea Plustek, LLC | 2013-04-01 |
| MENDEC SPINE HV, MENDEC SPINE HV SYSTEM (K122175) | Tecres S.P.A. | 2013-03-28 |
| ASCENDX VCF REDUCTION SYSTEM (K100404) | Aoi Medical, Inc. | 2012-12-14 |
| OSSEOFLEX SB INFLATABLE BONE TAMP (K122533) | Osseon Therapeutics, Inc. | 2012-10-23 |
| VERTECEM II CEMENT KIT (K121876) | Aap Biomaterials GmbH | 2012-10-19 |
| KMC KYPHOPLASTY SYSTEM (K113742) | Shanghai Kinetic Medical Co., Ltd. | 2012-09-17 |
| ACU-CUT VERTEBRAL AUGMENTATION SYSTEM (K113452) | Ascendx Spine, Inc. | 2012-02-17 |
| IVAS BALLOON CATHETER (K113154) | Stryker Corporation | 2012-01-24 |
| IVAS 20MM (10 GAUGE) BALLOON CATHETER (K113477) | Stryker Instruments, Instruments Div. | 2012-01-06 |
| CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G (K112907) | Medos International SARL | 2011-12-22 |
| VBB SYSTEM (K110604) | Synthes | 2011-12-13 |
| SHIELD KYPHOPLASTY SYSTEM (K093477) | Soteira, Inc. | 2011-12-08 |
| GUARDIAN INFLATABLE BONE EXPANDER SYSTEM (K111593) | Bm Korea Co., Ltd. | 2011-11-18 |
| AFFIRM (TM) VCF SYSTEM (K110998) | Algea Therapies | 2011-10-25 |
| IVAS 2-10MM (10 GUAGE) BALLON CATHETER (K103807) | Stryker Corporation | 2011-06-28 |
| KYPHON XPEDE BONE CEMENT (K102397) | Medtronic | 2011-02-28 |
| ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE (K110183) | Arthrocare Corp. | 2011-02-16 |
| COHESION BONE CEMENT (K103816) | Teknimed Sas | 2011-02-04 |
| AVAMAX VERTEBRAL BALLOON (K103064) | Care Fusion | 2011-01-10 |
| F20 (K103433) | Teknimed, S.A. | 2011-01-03 |
| PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE (K100479) | Arthrocare Corp. | 2010-09-21 |
| KYPH X HV-R BONE CEMENT (K093828) | Medtronic, Inc. | 2010-08-12 |
| IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS (K093419) | Stryker Instruments, Instruments Div. | 2010-03-18 |
| AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 (K093463) | Care Fusion | 2010-02-26 |
| SKELTEX ISV (K091234) | Skeltex Technologies, Inc. | 2010-02-16 |
| STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) (K090986) | Dfine, Inc. | 2009-12-30 |
| VERTECEM (K090435) | Teknimed, S.A. | 2009-12-21 |
| VERTAPLEX HV (SINGLE PACK AND DUAL PACK) (K091606) | Stryker Corp. | 2009-10-23 |
| INFLATABLE BONE TAMP (K090211) | Cardinal Health, Inc. | 2009-07-01 |
| CORTOSS BONE AUGMENTATION MATERIAL (K080108) | Orthovita, Inc. | 2009-06-05 |
| BONOS INJECT (K090460) | Aap Biomaterials GmbH | 2009-04-14 |
| OPACITY + BONE CEMENT (K080873) | Teknimed, S.A. | 2008-08-28 |
| MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) (K071375) | Disc-O-Tech Medical Technologies, Ltd. | 2007-12-21 |
| STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT (K072118) | Stryker Corp. | 2007-12-07 |
| MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT (K071927) | Depuy Spine, A Johnson & Johnson Company | 2007-11-21 |
| AVAFLEX VERTEBRAL AUGMENTATION NEEDLE (K072133) | Cardinal Health, Inc. | 2007-11-20 |
| MODIFICATION TO SPACE CPSXL BONE CEMENT (K072496) | Dfine, Inc. | 2007-10-05 |
| SPACE 360 DELIVERY SYSTEM (K070351) | Dfine, Inc. | 2007-06-29 |
| ARCUATE VERTEBRAL AUGMENTATION SYSTEM (K070527) | Medtronic Sofamor Danek | 2007-05-04 |
| ARCUATE VERTEBRAL AUGMENTATION SYSTEM (K063248) | Medtronic Sofamor Danek | 2007-03-13 |
| VSPSPN (K063438) | Tecres S.P.A. | 2007-01-17 |
| CONFIDENCE FENESTRATED INTRODUCER NEEDLE (K063067) | Disc-O-Tech Medical Technologies, Ltd. | 2006-11-03 |
| KIT MENDEC SPINE AND DELIVERY SYSTEM (K062452) | Tecres S.P.A. | 2006-09-21 |
| CONFIDENCE EX HIGH VISCOSITY BONE CEMENT (K062424) | Disc-O-Tech Medical Technologies, Ltd. | 2006-09-14 |
| SPACE CPSXL BONE CEMENT (K061531) | Dfine, Inc. | 2006-08-30 |
| PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA (K060425) | Arthrocare Corp. | 2006-07-12 |
| STAXX FX SYSTEM (K053336) | Spine Wave, Inc. | 2006-07-03 |
| CONFIDENCE HIGH VISCOSITY BONE CEMENT (K060300) | Disc-O-Tech Medical Technologies, Ltd. | 2006-06-21 |
| SPINE-FIX BIOMIMETIC BONE CEMENT (K043593) | Teknimed, S.A. | 2006-03-17 |
| EBI VERTEBROPLASTY SYSTEMS (K060148) | Ebi, L.P. | 2006-03-13 |
| PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS (K053180) | Arthrocare Corp. | 2006-01-25 |
| VERTEFIX VERTEBROPLASTY PROCEDURE SET (K042691) | Cook, Inc. | 2005-11-08 |