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

Name: FDA 510(k) clearance K182711
Creator: U.S. Food and Drug Administration
Published: 2019-05-21

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.. Device class: 2.

Clearance details

Applicant: Kelyniam Global, Inc.
Product code: Code GWO
Device class: Class 2
Regulation: 21 CFR 882.5320
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 ↗

Recent devices under product code GWO

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K262874 — CraniUS Plate2026-09-11
K261058 — CraniUS Plate2026-07-29
K250297 — TECHFIT Patient-Specific Cranial System2025-10-27
K250334 — Fusion Craniofacial Implant; Fusion Skull Implant2025-07-25
K231834 — VSP PEEK Cranial Implant2024-04-04

More clearances from Kelyniam Global, Inc.

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K121755 — CUSTOM CRANIOFACIAL IMPLANT (CCI)2012-09-25
K103582 — KELYNIAM CUSTOM SKULL IMPLANT (CSI)2011-04-14

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.