FDA.reportPublic FDA data

NEW ERA ORTHOPAEDICS, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30107601603010760160NEW ERA ORTHOPAEDICS, LLC1N2020-04-251011 Shadowmoss Circle Lake Mary FL US 32746

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1673701824688365K141253NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEMMNI2015-01-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MNI12015-01-09

PMN#