FDA.reportPublic FDA data

HyperFlex Medical Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30385035723038503572HyperFlex Medical Inc1N2026-01-01253 South 200 West STE 1 Richmond UT US 84333

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3400811062831903K252997HyperFlex® Bunion Correction SystemHRS2025-12-11
3400811657858098K241995HyperFlex™ Bunion Correction SystemHRS2024-11-26
3400811170468636

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS22025-12-11

PMN#

GUDID#