Product code PML
- Device name
- Bone Cement, Posterior Screw Augmentation
- 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
- Definition
- The device is intended to augment the fixation of screws in a posterior spinal system construct.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2026-01-22 |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | Medacta International S.A. | 2024-06-12 |
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement | Ulrich Medical USA | 2023-10-20 |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | Spineart | 2023-06-23 |
| K222789 | VADER® Pedicle System, G21 Cement | Icotec AG | 2023-01-09 |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022-12-20 |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System™ | Neo Medical SA | 2022-08-26 |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | 2021-10-28 |
| K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020-10-13 |
| K201362 | CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement | Medtronic | 2020-08-19 |
| K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System | Stryker Corporation | 2020-03-31 |
| K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics , Ltd. | 2019-09-19 |
| K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2019-09-12 |
| K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018-11-28 |
| K172269 | FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System | Globus Medical, Inc. | 2018-03-27 |
| K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set | Medtronic | 2017-10-23 |
| K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems | Medos International Sàrl | 2016-12-20 |
| K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016-01-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640164840758 | VADER Pedicle System, Cannula Guiding Sleeve | icotec AG | 2020-10-27 |
| 07640164844794 | VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 7.5 x 35 mm | icotec AG | 2020-10-27 |
| 07640164844787 | VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 7.5 x 30 mm | icotec AG | 2020-10-27 |
| 07640164844770 | VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 6.5 x 60 mm | icotec AG | 2020-10-27 |
| 07640164844763 | VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 6.5 x 55 mm | icotec AG | 2020-10-27 |
| 07640164844756 | VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 6.5 x 50 mm | icotec AG | 2020-10-27 |
| 07640164844527 | VADER Pedicle System Cement Cannula Sleeve MIS | icotec AG | 2020-10-27 |
| 07640164843995 | VADER Pedicle System Cement Sleeve S Container Lid | icotec AG | 2020-10-27 |
| 07640164843988 | VADER Pedicle System Cement Sleeve S Container Base | icotec AG | 2020-10-27 |
| 07640164841038 | VADER Pedicle System, VADER Pedicle System Cement Sleeve, Container Lid | icotec AG | 2020-10-27 |
| 07640164841021 | VADER Pedicle System, VADER Pedicle System Cement Sleeve, Container Base | icotec AG | 2020-10-27 |
| 07640164840741 | VADER Pedicle System, Outer Alignment Sleeve | icotec AG | 2020-10-27 |
| 07640164844800 | VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 7.5 x 40 mm | icotec AG | 2020-10-27 |
| 07640164844817 | VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 7.5 x 45 mm | icotec AG | 2020-10-27 |
| 07640164844824 | VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 7.5 x 50 mm | icotec AG | 2020-10-27 |
| 07640164844831 | VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 7.5 x 55 mm | icotec AG | 2020-10-27 |
| 07640164846378 | VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 100 mm | icotec AG | 2019-08-23 |
| 07640164846279 | icotec Pedicle System, Cross-Link, Ti, 30/34 mm | icotec AG | 2019-08-23 |
| 07640164846286 | icotec Pedicle System, Cross-Link, Ti, 33/42 mm | icotec AG | 2019-08-23 |
| 07640164846293 | icotec Pedicle System, Cross-Link, Ti, 40/53 mm | icotec AG | 2019-08-23 |
| 07640164846309 | icotec Pedicle System, Cross-Link, Ti, 50/70 mm | icotec AG | 2019-08-23 |
| 07640140431994 | icotec Pedicle System, Nut Screw, Ti | icotec AG | 2019-08-23 |
| 07613327357851 | PCD, VertaPlex | STRYKER CORPORATION | 2017-04-21 |
| 07613252039259 | AutoPlex, VertaPlex | STRYKER CORPORATION | 2017-01-03 |
| 07613252018315 | PCD, VertaPlex | STRYKER CORPORATION | 2016-12-29 |
| 07613327170566 | VertaPlex | STRYKER CORPORATION | 2016-09-23 |
| 07613327170559 | VertaPlex HV | STRYKER CORPORATION | 2016-09-23 |
| 07613327141764 | VertaPlex | STRYKER CORPORATION | 2016-09-23 |
| 07613252254430 | VertaPlex | STRYKER CORPORATION | 2016-09-23 |
| 07613154757091 | VertaPlex | STRYKER CORPORATION | 2016-06-30 |