FDA.reportPublic FDA data

ORTHO OUTCOMES, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30353737973035373797ORTHO OUTCOMES, LLC1N2026-01-012490 S 300 W Salt Lake City UT US 84115

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3361821051961896K230867Bone Bolt SystemHWC2023-06-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC12023-06-26

GUDID#