Kelyniam Global, Inc. - FDA 510(k) Cleared Devices
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Kelyniam Global, Inc. Neurology ✕
4 devices
Cleared
Jul 25, 2025
Fusion Craniofacial Implant
Neurology
170d
Cleared
May 21, 2019
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
Neurology
236d
Cleared
Sep 25, 2012
CUSTOM CRANIOFACIAL IMPLANT (CCI)
Neurology
102d
Cleared
Apr 14, 2011
KELYNIAM CUSTOM SKULL IMPLANT (CSI)
Neurology
127d