FDA.reportPublic FDA data

OMNIlife science, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30136821463013682146OMNIlife science, Inc.1N2026-01-01880 N McCarthy Blvd Suite 220 Milpitas CA US 95035
30136821463013682146OMNIlife science, Inc.1N2020-04-255201 Great America Parkway Suite 240 Santa Clara CA US 95054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3467951434519917K241808ApolloHipX (THR.SS.0001)LLZ2025-01-07
3467951685673916K231172ApolloKneeOLO2023-07-26
3467951578907887K200888OMNIBotics Knee SystemOLO2020-06-27
3467951659808503K163338OMNIBotics Knee SystemOLO2017-09-01
2076061757401851K163338OMNIBotics Knee SystemOLO2017-09-01
3467951844291946K090953TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCKOLO2010-01-21
2076061897221550K090953TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCKOLO2010-01-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLO62023-07-26
LLZ12025-01-07