510(k) K260286— Dynamo Spinal Cement; Salvo® Spine System

Substantially Equivalent

Spine Wave, Inc.

Clearance details

Applicant: Spine Wave, Inc.
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2026-01-29
Decision date: 2026-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

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.