Panels › Orthopedic › Product code PML · Class 2
Bone Cement, Posterior Screw Augmentation
Regulation 888.3027
2510(k)s in 12 months (19 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PML
| Company | 510(k)s | Recalls |
|---|---|---|
| Icotec AG | 2 | 2 |
| Medtronic | 2 | 0 |
| Medtronic Sofamor Danek USA, Inc. | 2 | 0 |
| Neo Medical SA | 2 | 0 |
| Alphatec Spine, Inc. | 1 | 0 |
| Astura Medical | 1 | 0 |
| CarboFix Orthopedics , Ltd. | 1 | 0 |
| Globus Medical, Inc. | 1 | 0 |
| Medacta International S.A. | 1 | 0 |
| Medos International Sàrl | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2026 | K260286 | Dynamo Spinal Cement; Salvo® Spine System Spine Wave, Inc. | PML |
| Jan 22, 2026 | K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System Astura Medical | PML |
| Jun 12, 2024 | K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System Medacta International S.A., CH | PML |
| Oct 20, 2023 | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System Ulrich Medical USA | PML |
| Jun 23, 2023 | K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement Spineart, CH | PML |
| Jan 9, 2023 | K222789 | VADER® Pedicle System, G21 Cement Icotec AG, CH | PML |
| Dec 20, 2022 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System Alphatec Spine, Inc. | PML |
| Aug 26, 2022 | K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System Neo Medical SA, CH | PML |
| Oct 28, 2021 | K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System Neo Medical SA, CH | PML |
| Oct 13, 2020 | K200596 | G21 Cement, VADER® Pedicle System Icotec AG, CH | PML |
| Aug 19, 2020 | K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement Medtronic | PML |
| Mar 31, 2020 | K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System Stryker Corporation | PML |
| Sep 19, 2019 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws CarboFix Orthopedics , Ltd., IL | PML |
| Sep 12, 2019 | K191148 | Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set Medtronic Sofamor Danek USA, Inc. | PML |
| Nov 28, 2018 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement Nu Vasive, Incorporated | PML |
| Mar 27, 2018 | K172269 | FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Scr Globus Medical, Inc. | PML |
| Oct 23, 2017 | K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set Medtronic | PML |
| Dec 20, 2016 | K160879 | CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems Medos International Sàrl, CH | PML |
| Jan 6, 2016 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set Medtronic Sofamor Danek USA, Incorporated | PML |
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