FDA.reportPublic FDA data

VIRAK ORTHOPEDICS LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30108602273010860227VIRAK ORTHOPEDICS LLC1N2026-01-01345 Main St Ste 202 Madison NJ US 07940

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1701001382756906K192465DigiFix Sterile KitJEC2019-10-10
1701001081900164K132731DIGIFIX EXTERNAL FIXATION SYSTEMJEC2014-01-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JEC22019-10-10

PMN#

GUDID#