Avitus Bone Harvester BH8

GUDID 00857373006005

A manual surgical instrument that cuts cancellous bone by manual actuation of the 8mm cutting tip. The cap contains a barbed nozzle that connects to standard sized suction tubing (tube with an ID of 6–10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressure between 150 mmHg and 300 mmHg. The proposed device can be connected to a waste canister that leads to standard operating room wall suction or to an external pump. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone graft inside the handle. The suction pulls the bone and bone marrow from the cutting tip and into the bone reservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bone graft can be retrieved from the handle.

AVITUS ORTHOPAEDICS, INC.

Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter Bone graft harvesting filter

• Primary Device ID: 00857373006005
• NIH Device Record Key: 6a2e022c-4143-4f6d-8fbd-a7f444c95aae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avitus Bone Harvester
• Version Model Number: BH8
• Catalog Number: BH8
• Company DUNS: 078269403
• Company Name: AVITUS ORTHOPAEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857373006005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152474

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-23

On-Brand Devices [Avitus Bone Harvester]

• 00857373006050: A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting ti
• 00857373006036: A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting ti
• 00857373006029: Filter Accessory for REF: BH8 ONLY
• 00857373006005: A manual surgical instrument that cuts cancellous bone by manual actuation of the 8mm cutting ti
• 00857373006074: Sterile, disposable surgical instrument with 6mm cutting tip for large volume, cancellous bone a