FDA.reportPublic FDA data

OVERTURE ORTHOPAEDICS

Matched from indexed company URL: Overture Orthopaedics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30277378263027737826OVERTURE ORTHOPAEDICS1N2026-01-015 Peters Canyon Rd Ste 160 Irvine CA US 92606

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3193561898957216K242746OvertureTi Knee Resurfacing SystemTMHSX2024-10-07
3193562069110597K221292Uni Knee Resurfacing SystemHSX2023-03-10
3193561253813568
3193561638624721
3193561681265229

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HSX22024-10-07

PMN#

GUDID#

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