FDA.reportPublic FDA data

Avitus Bone Harvester

Primary DI
00857373006029
Brand
Avitus Bone Harvester
Company
AVITUS ORTHOPAEDICS, INC.
Model
FI-100
Catalog number
FI-100
Device description
Filter Accessory for REF: BH8 ONLY
Published
2017-11-07
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

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
K170539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170539000Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mmAvitus Orthopaedics, Inc.2017-03-20KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857373006029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857373006029008573730060298573730060290857373006029

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

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
00857373006005Avitus Bone HarvesterBH8BH82016-05-23
00857373006036Avitus Bone HarvesterBH-210BH-2102017-11-03
00857373006050Avitus Bone HarvesterBH-110BH-1102018-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
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