Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Kelyniam Global, Inc. with 4 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated Jul 25, 2025: Fusion Craniofacial Implant; Fusion Skull Implant.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 25, 2025 | Fusion Craniofacial Implant; Fusion Skull ImplantK250334 · GWO | 510(k) clearances |
| May 21, 2019 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)K182711 · GWO | 510(k) clearances |
| Jun 10, 2017 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003Class II · Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across | Device recalls |
| Jun 10, 2017 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004Class II · Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across | Device recalls |
| Jun 10, 2017 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)Class II · Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across | Device recalls |
| Jun 10, 2017 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002Class II · Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across | Device recalls |
| Sep 25, 2012 | CUSTOM CRANIOFACIAL IMPLANT (CCI)K121755 · GXN | 510(k) clearances |
| Apr 14, 2011 | KELYNIAM CUSTOM SKULL IMPLANT (CSI)K103582 · GXN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
