PML

Bone Cement, Posterior Screw Augmentation

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-06-15.

NumberDecision dateApplicantDevice nameSummary
K2602862026-06-15Spine Wave, Inc.Dynamo™ Spinal Cement; Salvo® Spine SystemPDF
K2528852026-01-22Astura MedicalOLYMPIC Posterior Spinal Fixation System; MASADA ModPDF
K2410342024-06-12Medacta International S.A.Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle ScrPDF
K2318092023-10-20Ulrich Medical USAMomentum® Posterior Spinal Fixation System with G21 PDF

4 summaries are archived here for direct download.

Official FDA classification page: PML
Classification and pathway per current FDA publications. Data from openFDA (CC0).