FDA.reportPublic FDA data

BLUE ORTHO

Matched from indexed company URL: Blue Ortho

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30080279123008027912BLUE ORTHO1N2026-01-0122 Chemin du Vieux Chene Meylan Isere FR 38240

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1305771736596634K233299ExactechGPS® SystemOLO2024-01-26
1305772037229666K232521ExactechGPS® Total Ankle ApplicationOLO2023-11-16
1305772027485855K213877ExactechGPS® SystemOLO2022-05-02
1305771847296525K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareOLO2022-01-06
1305771284482384K193618ExactechGPS SystemOLO2020-09-02
1305771706986241K173372ExactechGPS Total Shoulder ApplicationOLO2017-11-24
1305771670714970K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareOLO2017-04-05
1305771399897448K152764EXACTECH GPSHAW2016-07-13
1305771055990563K100742EXACTECH GPSOLO2010-10-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLO82024-01-26
HAW12016-07-13

PMN#