Invictus® Bone Cement, Invictus Spinal Fixation System— 510(k) K221926

Substantially Equivalent

Alphatec Spine, Inc.

FDA 510(k) clearance K221926 for Invictus® Bone Cement, Invictus Spinal Fixation System, Substantially Equivalent on 2022-12-20. Applicant: Alphatec Spine, Inc..

Clearance details

Applicant: Alphatec Spine, Inc.
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2022-07-01
Decision date: 2022-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, 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.