Company ยท US
Kelyniam Global, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2025. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 25, 2025 | K250334 | Fusion Craniofacial Implant; Fusion Skull Implant Kelyniam Global, Inc. | GWO |
| May 21, 2019 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) Kelyniam Global, Inc. | GWO |
| Sep 25, 2012 | K121755 | CUSTOM CRANIOFACIAL IMPLANT (CCI) Kelyniam Global, Inc. | GXN |
| Apr 14, 2011 | K103582 | KELYNIAM CUSTOM SKULL IMPLANT (CSI) Kelyniam Global, Inc. | GXN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2017 | Kelyniam Global, Inc. Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004 Terminated |
GXN | K103582 |
| Jun 10, 2017 | Kelyniam Global, Inc. Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003 Terminated |
GXN | K103582 |
| Jun 10, 2017 | Kelyniam Global, Inc. Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002 Terminated |
GXN | K103582 |
| Jun 10, 2017 | Kelyniam Global, Inc. Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) Terminated |
GXN | K103582 |