FDA.reportPublic FDA data

Avitus Orthopaedics, Inc

Matched from indexed company URL: AVITUS ORTHOPAEDICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30115049933011504993Avitus Orthopaedics, Inc1N2026-01-016 Armstrong Rd., Suite 107 Shelton CT US 06484

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00857373006012Avitus Pilot Hole Creator, Disposable - 8mm - Disposable surgical instrument with 8mm tip for manually cutting a hole into bone allowing access to cancellous bone.8606379922neil@avitusortho.com
00857373006012Avitus Pilot Hole Creator, Disposable - 8mm - Disposable surgical instrument with 8mm tip for manually cutting a hole into bone allowing access to cancellous bone.8603727213maxim@avitusortho.com
00857373006067Avitus Pilot Hole Creator, Disposable - 11mm - Disposable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone.8606379922neil@avitusortho.com
00857373006067Avitus Pilot Hole Creator, Disposable - 11mm - Disposable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone.8603727213maxim@avitusortho.com
00857373006104Avitus Pilot Hole Creator - 11mm - Reusable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone.8606379922neil@avitusortho.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1940541578786700K231456Avitus® DragonWing Large Volume Autograft Delivery SystemFMF2023-07-17
1940541664626211K230492Avitus® 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#

GUDID#

Avitus Bone Harvester - A manual surgical instrument that cuts cancellous bone by manual actuation of the8mm cutting tip. The cap contains a barbed nozzle that connects to standard sized suction tubing (tube with an IDof 6–10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressurebetween 150 mmHg and 300 mmHg. The proposed device can be connected to a waste canister that leads tostandard operating room wall suction or to an external pump. With the device connected to a vacuumsource, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bonegraft inside the handle. The suction pulls the bone and bone marrow from the cutting tip and into the bonereservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into thesuction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bonegraft can be retrieved from the handle.

AVITUS ORTHOPAEDICS, INC.

2016-05-23