ChM 4.5mm Cortical screws— 510(k) K210490

Substantially Equivalent

Chm Sp. Z O.O.

FDA 510(k) clearance K210490 for ChM 4.5mm Cortical screws, Substantially Equivalent on 2021-10-05. Applicant: Chm Sp. Z O.O..

Clearance details

Applicant: Chm Sp. Z O.O.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2021-02-19
Decision date: 2021-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Juchnowiec Koscielny, PL

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.