PML
- Product code
- PML
- Device name
- Bone Cement, Posterior Screw Augmentation
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3027
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 19 (all years; only the last 3 years are listed here)
FDA classification definition
The device is intended to augment the fixation of screws in a posterior spinal system construct.
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260286 | 2026-06-15 | Spine Wave, Inc. | Dynamo Spinal Cement; Salvo® Spine System | |
| K252885 | 2026-01-22 | Astura Medical | OLYMPIC Posterior Spinal Fixation System; MASADA Mod | |
| K241034 | 2024-06-12 | Medacta International S.A. | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Scr | |
| K231809 | 2023-10-20 | Ulrich Medical USA | Momentum® Posterior Spinal Fixation System with G21 |
Official FDA classification page: PML
Classification and pathway per current FDA publications. Data from openFDA (CC0).