FDA.reportPublic FDA data

ASTRA ORTHOMED, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30415019613041501961ASTRA ORTHOMED, INC.1N2026-01-017842 Hickory Flat Hwy Woodstock GA US 30188

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3442891164410896K251382Phoenix Sinus Tarsi Stent SystemHWC2025-08-27
3442891752939400

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC12025-08-27