Avitus Bone Harvester - A manual surgical instrument that cuts cancellous - AVITUS ORTHOPAEDICS, INC.

Duns Number:078269403

Device Description: A manual surgical instrument that cuts cancellous bone by manual actuation of the8mm cutti 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.

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More Product Details

Catalog Number

BH8

Brand Name

Avitus Bone Harvester

Version/Model Number

BH8

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K152474

Product Code Details

Product Code

KNW

Product Code Name

Instrument, Biopsy

Device Record Status

Public Device Record Key

6a2e022c-4143-4f6d-8fbd-a7f444c95aae

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

May 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVITUS ORTHOPAEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5