Dev4

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30298940433029894043Dev41N2026-01-011002 Gemini st. suite 129 Houston TX US 77058

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3224451280642376K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)HWC2025-10-10
3224451781053104K250251Eleganz Fusion Screw System (Fusion Screw System)HWC2025-06-13
3224451634526795

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC22025-10-10

PMN#

GUDID#

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