Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)— 510(k) K182711

Substantially Equivalent

Kelyniam Global, Inc.

FDA 510(k) clearance K182711 for Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI), Substantially Equivalent on 2019-05-21. Applicant: Kelyniam Global, Inc..

Clearance details

Applicant: Kelyniam Global, Inc.
Product code: Code GWO
Advisory panel: Neurology
Date received: 2018-09-27
Decision date: 2019-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.