FDA.reportPublic FDA data

FUZE

Primary DI
00841731115652
Brand
FUZE
Company
VILEX LLC
Model
FZ410-080
Device description
Reamer, FUZE Canal 08.0mm
Published
2017-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102413000FUZE: INTRAMEDULLARY INTERNAL FIXATION NAILVilex, Inc.2011-11-14HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731115652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731115652008417311156528417311156520841731115652

GMDN Terms#

Term, Definition table
TermDefinition
Medullary canal orthopaedic reamer, rigidAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117502293
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731147431OPTIXOX2-0011OX2-00112026-03-03
00841731140395ARTEMIS FUZEAV40-20T-16V2026-07-22
00841731140401ARTEMIS FUZEAV40-22T-16V2026-07-22
00841731140418ARTEMIS FUZEAV40-24T-16V2026-07-22
00841731140425ARTEMIS FUZEAV40-26T-16V2026-07-22
00841731140432ARTEMIS FUZEAV40-28T-16V2026-07-22
00841731140449ARTEMIS FUZEAV40-30T-16V2026-07-22
00841731140456ARTEMIS FUZEAV40-32T-16V2026-07-22
00841731140463ARTEMIS FUZEAV40-34T-16V2026-07-22
00841731140470ARTEMIS FUZEAV40-36T-16V2026-07-22
00841731140487ARTEMIS FUZEAV40-38T-16V2026-07-22
00841731140494ARTEMIS FUZEAV40-40T-16V2026-07-22
00841731140500ARTEMIS FUZEAV40-42T-16V2026-07-22
00841731140517ARTEMIS FUZEAV40-44T-16V2026-07-22
00841731140524ARTEMIS FUZEAV40-46T-16V2026-07-22
00841731140531ARTEMIS FUZEAV40-48T-16V2026-07-22
00841731140548ARTEMIS FUZEAV40-50T-16V2026-07-22
00841731140555ARTEMIS FUZEAV40-52T-16V2026-07-22
00841731140562ARTEMIS FUZEAV40-54T-16V2026-07-22
00841731140593ARTEMIS FUZEAV30-16T-11V2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982471415AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471439AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471453AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471477AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471491AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471514AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471538AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471767AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471781AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471804AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471828AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471842AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471866AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982471880AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472115AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472139AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472153AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472177AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472191AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472214AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982472238AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473822AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473846AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473860AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473884AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473907AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473921AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982473945AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982474171AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14
00193982474195AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-08-14