Avitus Orthopaedics, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30115049933011504993Avitus Orthopaedics, Inc1N2027-01-016 Armstrong Rd., Suite 107 Shelton CT US 06484

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1940541578786700K231456AvitusĀ® DragonWing Large Volume Autograft Delivery SystemFMF2023-07-17
1940541664626211K230492AvitusĀ® Precision Autograft Delivery SystemFMF2023-06-26
1940541099832773K210631Avitus(r) Bone HarvesterKNW2021-03-31
1940541734292583K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mmKNW2017-03-20
1940542055524343K152474Avitus Bone HarvesterKNW2015-10-23
1940541045795883
1940541967561222

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNW32021-03-31
FMF22023-07-17

PMN#