Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement— 510(k) K231809

Substantially Equivalent

Ulrich Medical USA

FDA 510(k) clearance K231809 for Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement, Substantially Equivalent on 2023-10-20. Applicant: Ulrich Medical USA.

Clearance details

Applicant: Ulrich Medical USA
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2023-06-20
Decision date: 2023-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PML

product code PML

Death: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.