avitusortho.comAvitus® DragonWing Large Volume Autograft Delivery System
Avitus Orthopaedics, Inc.
Avitus Orthopaedics, Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011504993 | 3011504993 | Avitus Orthopaedics, Inc | 1 | N | 2026-01-01 | 6 Armstrong Rd., Suite 107 Shelton CT US 06484 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00857373006012 | Avitus Pilot Hole Creator, Disposable - 8mm - Disposable surgical instrument with 8mm tip for manually cutting a hole into bone allowing access to cancellous bone. | 8606379922 | neil@avitusortho.com |
| 00857373006012 | Avitus Pilot Hole Creator, Disposable - 8mm - Disposable surgical instrument with 8mm tip for manually cutting a hole into bone allowing access to cancellous bone. | 8603727213 | maxim@avitusortho.com |
| 00857373006067 | Avitus Pilot Hole Creator, Disposable - 11mm - Disposable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone. | 8606379922 | neil@avitusortho.com |
| 00857373006067 | Avitus Pilot Hole Creator, Disposable - 11mm - Disposable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone. | 8603727213 | maxim@avitusortho.com |
| 00857373006104 | Avitus Pilot Hole Creator - 11mm - Reusable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone. | 8606379922 | neil@avitusortho.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 194054 | 1578786700 | K231456 | Avitus® DragonWing Large Volume Autograft Delivery System | FMF | 2023-07-17 |
| 194054 | 1664626211 | K230492 | Avitus® Precision Autograft Delivery System | FMF | 2023-06-26 |
| 194054 | 1099832773 | K210631 | Avitus(r) Bone Harvester | KNW | 2021-03-31 |
| 194054 | 1734292583 | K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm | KNW | 2017-03-20 |
| 194054 | 2055524343 | K152474 | Avitus Bone Harvester | KNW | 2015-10-23 |
| 194054 | 1045795883 | ||||
| 194054 | 1967561222 |
Product Codes Associated With Registrations#
PMN#
Avitus® Precision Autograft Delivery System
Avitus Orthopaedics, Inc.
Avitus(r) Bone Harvester
Avitus Orthopaedics, Inc.
Avitus Bone Harvester With Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester With Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
Avitus Orthopaedics, Inc
Avitus Bone Harvester
Avitus Orthopaedics Inc.
GUDID#
Avitus Pilot Hole Creator, Disposable - 8mm - Disposable surgical instrument with 8mm tip for manually cutting a hole into bone allowing access to cancellous bone.
2022-12-08
Avitus Pilot Hole Creator, Disposable - 11mm - Disposable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone.
2022-12-08
Avitus Pilot Hole Creator - 11mm - Reusable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone.
2022-12-08
Avitus Surgical Tray - Surgical tray to store the PH11, and other Avitus devices intended for the tray, during sterilization, aseptic presentation, and transportation within the hospital.
2022-12-08
Avitus ® Bone DebriderTM – Ø8mm, 255mm Shaft Length - Sterile, disposable surgical instrument with 8mm cutting tip for large volume debridement of cancellous bone, bio film and marrow.
2024-07-08
DragonWing - Avitus DragonWing Large Volume Autograft Delivery (Ø5.2mm, 120mm system)
2023-08-28
ArchiMIS - Avitus® ArchiMIS Precision Autograft Delivery (Ø4.0mm, 120mm system)
2023-07-19
Avitus Bone Harvester - Sterile, disposable surgical instrument with 6mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.
2020-10-08
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.
2016-05-23
Avitus Bone Harvester - Filter Accessory for REF: BH8 ONLY
2017-11-07
Avitus Bone Harvester - Sterile, disposable surgical instrument with 5mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.
2017-11-03
Avitus Bone Harvester - Sterile, disposable surgical instrument with 8mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.
2018-03-16