FDA Product Code
FDA Product Code PML — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3027
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine System | Spine Wave, Inc. | 2026-06-15 | Traditional | PDF ↗ |
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2026-01-22 | Traditional | PDF ↗ |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | Medacta International S.A. | 2024-06-12 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | Spineart | 2023-06-23 | Traditional | PDF ↗ |
| K222789 | VADER® Pedicle System, G21 Cement | Icotec AG | 2023-01-09 | Traditional | PDF ↗ |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022-12-20 | Traditional | PDF ↗ |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | 2022-08-26 | Special | PDF ↗ |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | 2021-10-28 | Traditional | PDF ↗ |
| K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020-10-13 | Traditional | PDF ↗ |
| K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement | Medtronic | 2020-08-19 | Traditional | PDF ↗ |
| K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System | Stryker Corporation | 2020-03-31 | Traditional | PDF ↗ |
| K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics , Ltd. | 2019-09-19 | Traditional | PDF ↗ |
| K191148 | Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2019-09-12 | Traditional | PDF ↗ |
| K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018-11-28 | Traditional | PDF ↗ |
| K172269 | FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System | Globus Medical, Inc. | 2018-03-27 | Traditional | PDF ↗ |
| K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set | Medtronic | 2017-10-23 | Traditional | PDF ↗ |
| K160879 | CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems | Medos International Sàrl | 2016-12-20 | Traditional | PDF ↗ |
| K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016-01-06 | Traditional | PDF ↗ |
Product code PML · Class II · Orthopedic. Data: openFDA.