FDA.reportPublic FDA data

SAIL FUSION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30310247163031024716SAIL FUSION1N2026-01-012010 Jimmy Durante Blvd Ste 200 Del Mar CA US 92014

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3361051616393087K232149BowTie™ SI Joint Fusion SystemOUR2024-04-20
3361051363881170
3361051512392139

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OUR12024-04-20

PMN#

GUDID#

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