FDA.reportPublic FDA data

KELYNIAM GLOBAL INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30094247963009424796KELYNIAM GLOBAL INC.1N2026-01-0197 RIVER RD STE A COLLINSVILLE CT US 06019

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2076891730748902K250334Fusion Craniofacial Implant; Fusion Skull ImplantGWO2025-07-25
2076891396110013K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)GWO2019-05-21
2076891082731479K121755CUSTOM CRANIOFACIAL IMPLANT (CCI)GXN2012-09-25
2076891370407490K103582KELYNIAM CUSTOM SKULL IMPLANT (CSI)GXN2011-04-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWO22025-07-25
GXN22012-09-25

PMN#

GUDID#

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