Avitus Bone Harvester

Primary DI
00857373006005
Brand
Avitus Bone Harvester
Company
AVITUS ORTHOPAEDICS, INC.
Model
BH8
Catalog number
BH8
Device description
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.
Published
2016-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152474000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152474000Avitus Bone HarvesterAvitus Orthopaedics, Inc.2015-10-23KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857373006005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857373006005008573730060058573730060050857373006005

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft harvesting filterA sterile receptacle designed to collect morselized (cut/shredded into small pieces) bone and bone marrow typically obtained during an intramedullary procedure involving reaming, irrigation, and aspiration (suction). The filter is situated, with connection tubing, between the bone harvesting device (e.g., the orthopaedic reamer handpiece) and a suction system which creates vacuum to draw the graft into the filter where it is captured. The retrieved tissue is used for surgical procedures requiring bone graft (e.g., to facilitate bone fusion and/or fill bone defects). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8606379922neil@avitusortho.com
8606379295jeff@avitusortho.com
8603727213maxim@avitusortho.com

Regulatory Flags#

DUNS number
078269403
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857373006012Avitus Pilot Hole Creator, Disposable - 8mmPC-200PC-2002022-12-08
00857373006067Avitus Pilot Hole Creator, Disposable - 11mmPC-100PC-1002022-12-08
00857373006104Avitus Pilot Hole Creator - 11mmPH11PH112022-12-08
00857373006135Avitus Surgical TrayST-01ST-012022-12-08
00857373006142Avitus ® Bone DebriderTM – Ø8mm, 255mm Shaft LengthBH-330BH-3302024-07-08
00857373006128DragonWingAD-5ch-5.2-120AD-5ch-5.2-1202023-08-28
00857373006111ArchiMISAD-1ch-4.0-120AD-1ch-4.0-1202023-07-19
00857373006074Avitus Bone HarvesterBH-220BH-2202020-10-08
00857373006029Avitus Bone HarvesterFI-100FI-1002017-11-07
00857373006036Avitus Bone HarvesterBH-210BH-2102017-11-03
00857373006050Avitus Bone HarvesterBH-110BH-1102018-03-16

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