High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws— 510(k) K190526

Substantially Equivalent

CarboFix Orthopedics , Ltd.

FDA 510(k) clearance K190526 for High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws, Substantially Equivalent on 2019-09-19. Applicant: CarboFix Orthopedics , Ltd..

Clearance details

Applicant: CarboFix Orthopedics , Ltd.
Product code: Code PML
Advisory panel: Orthopedic
Date received: 2019-03-04
Decision date: 2019-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herzeliya, IL

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.