FDA.reportPublic FDA data

INNOVATIVE STERILIZATION TECHN

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30107727583010772758INNOVATIVE STERILIZATION TECHN1N2026-01-017625 PARAGON RD STE A Dayton OH US 45459

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1676261399491585K250029ONE TRAY® Sealed Sterilization Container SystemKCT2025-05-01
1676261471849828K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment DeviceKCT2021-12-28
1676262045327613K211007EZ-TRAXTM Persona Knee Containment DeviceKCT2021-07-01
1676262053742543K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceKCT2020-12-02
1676261029440269K192487EZ-TRAX Containment DeviceKCT2019-12-23
1676261816791561K052567ONE TRAY SEALED STERILIZATION CONTAINERKCT2006-03-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KCT72025-05-01

GUDID#