Product code NDN
- Device name
- Cement, Bone, Vertebroplasty
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3027
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251896 | XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed , Ltd. | 2026-01-28 |
| K250637 | VCFix Spinal System | Amber Implants | 2025-05-30 |
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement System | Xelite Biomed , Ltd. | 2025-04-11 |
| K241775 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement | Xelite Biomed , Ltd. | 2024-09-18 |
| K232842 | Balloon Inflation System | Ningbo Hicren Biotechnology Co., Ltd. | 2024-02-29 |
| K240084 | V-STRUT® Vertebral Implant | Hyprevention | 2024-02-09 |
| K231340 | Renova Spine Balloon Catheter | Biopsybell S.R.L. | 2023-10-30 |
| K221697 | INJECTION PIN (KIP(02031-02061) (03031-03061)) | Slk Ortho, LLC | 2023-03-03 |
| K223294 | SpineJack® Expansion Kit | Stryker Instruments | 2022-12-20 |
| K220131 | KYPHON VuE Bone Cement | Tecres S.P.A. | 2022-04-18 |
| K211797 | TRACKER Plus Kyphoplasty System | GS Medical Co., Ltd. | 2021-10-28 |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement | Stryker Instruments | 2021-06-25 |
| K202393 | SpineJack Expansion Kit | Stryker Corporation | 2020-10-20 |
| K201831 | CONFIDENCE Spinal Cement System | Depuy Spine, Inc. | 2020-08-31 |
| K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | 2020-05-27 |
| K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | 2020-03-05 |
| K192335 | TRACKER Kyphoplasty System | GS Medical Co., Ltd. | 2019-12-04 |
| K192403 | VK100 Percutaneous Vertebral Augmentation System | Bonwrx, Ltd. | 2019-11-08 |
| K181262 | SpineJack Expansion Kit | Vexim SA | 2018-08-30 |
| K172871 | SpineKure Kyphoplasty System | Hanchang Co., Ltd. | 2018-05-29 |
| K180700 | KYPHON HV-R Bone Cement | Medtronic Sofamor Danek USA, Inc. | 2018-05-18 |
| K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G-21 S.R.L. | 2017-08-23 |
| K161114 | HIGH V+ | Teknimed Sas | 2017-04-12 |
| K163032 | Kyphon Xpede Bone Cement | Medtronic, Inc. | 2017-02-27 |
| K162283 | DCM Kyphoplasty System | Dragon Crown Medical Co., Ltd. | 2017-02-06 |
| K162618 | CONCORD Plus Radiopaque Bone Cement | Globus Medical, Inc. | 2017-01-23 |
| K162453 | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) | Pan Medical , Ltd. | 2016-11-01 |
| K160983 | Kyphon HV-R Bone Cement | Medtronic, Inc. | 2016-08-24 |
| K153296 | MEDINAUT Kyphoplasty System | Imedicom Co., Ltd. | 2016-07-29 |
| K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters | G21, S.R.L. | 2016-02-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08058964729774 | Easy Winch 13 G, 10 mm | G21 SRL | 2026-10-19 |
| 08058964729767 | Easy Winch 13 G, 15 mm | G21 SRL | 2026-10-19 |
| 00763000750053 | CD HORIZON® Fenestrated Screw Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-16 |
| 00763000750251 | CD HORIZON® Fenestrated Screw Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-16 |
| 00763000750268 | CD HORIZON® Fenestrated Screw Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-16 |
| 00763000750275 | CD HORIZON® Fenestrated Screw Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-16 |
| 00763000750374 | CD HORIZON® Fenestrated Screw Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-16 |
| 00763000750404 | CD HORIZON® Fenestrated Screw Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-16 |
| 03701505801204 | Dynamo | TEKNIMED | 2026-02-02 |
| 03701505800528 | Invictus® Bone Cement | TEKNIMED | 2023-02-17 |
| 03760177046276 | Osteofix | TEKNIMED | 2020-09-25 |
| 03760177046313 | Synth-X SL | TEKNIMED | 2020-09-24 |
| 03760177046283 | Thermalfix | TEKNIMED | 2020-09-24 |
| 00815212023439 | VERTEFIX Plus US | TEKNIMED | 2020-09-24 |
| 03760177041721 | HIGH V+ | TEKNIMED | 2017-08-22 |
| 00844856032231 | Osseofix + | ALPHATEC SPINE, INC. | 2016-10-28 |
| 03760177040113 | OPACITY + | TEKNIMED | 2015-10-16 |
| 03760177043954 | VERTEMEND | TEKNIMED | 2015-10-16 |
| 03760177043947 | CONFIDENCE | TEKNIMED | 2015-10-16 |
| 03760177043930 | VERTEFIX | TEKNIMED | 2015-10-16 |
| 03760177043923 | COHESION | TEKNIMED | 2015-10-16 |
| 03760177043060 | ZVplasty | TEKNIMED | 2015-10-16 |
| 03760177042933 | OSTEOFLEX | TEKNIMED | 2015-10-16 |
| 03760177042391 | EXOFIX | TEKNIMED | 2015-10-16 |
| 03760177042384 | SPINE-FIX US | TEKNIMED | 2015-10-16 |
| 03760177041677 | KYPHON ACTIVOS 10 | TEKNIMED | 2015-10-16 |
| 03760177041110 | F20 | TEKNIMED | 2015-10-16 |
| 03760177041080 | SINPLUS S | TEKNIMED | 2015-10-16 |
| 00808232000979 | Cortoss | Stryker Corporation | 2015-09-24 |
| 00808232000962 | Cortoss | Stryker Corporation | 2015-09-24 |