KELYNIAM CUSTOM SKULL IMPLANT (CSI)— 510(k) K103582

Substantially Equivalent

Kelyniam Global, Inc.

FDA 510(k) clearance K103582 for KELYNIAM CUSTOM SKULL IMPLANT (CSI), Substantially Equivalent on 2011-04-14. Applicant: Kelyniam Global, Inc..

Clearance details

Applicant: Kelyniam Global, Inc.
Product code: Code GXN
Advisory panel: Neurology
Date received: 2010-12-08
Decision date: 2011-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Britain, CT, US

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Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.