FDA.reportPublic FDA data

NOVAPPROACH SPINE, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30203073033020307303NOVAPPROACH SPINE, LLC1N2026-01-0113900 Tech City Circle Suite 300 Alachua FL US 32615

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2961632018148754K211769OneLIF Intervertebral Body Replacement SystemOVD2021-09-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OVD12021-09-07