FDA.reportPublic FDA data

Vilex Jones Fracture Tool

Primary DI
00841731123220
Brand
Vilex Jones Fracture Tool
Company
VILEX LLC
Model
JF-Guide-55
Device description
Drill/Tap Guide, JF 5.5mmScrews
Published
2019-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191289000Bone Screw Line AdditionVilex IN Tennessee, Inc.2019-07-29HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731123220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731123220008417311232208417311232200841731123220

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

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
00841731135483TITANEX H4102026-05-15
00841731135568TITANEX K150-16SC2026-05-15
00841731137319TITANEX ART-KW2-1012026-05-15
00841731137906TITANEXK150-09S2026-05-15
00841731137913TITANEX TH-DRILL-202026-05-15
00841731137920TITANEX TH-DRILL-252026-05-15
00841731137937TITANEXTH-DEPTHTH-DEPTH2026-05-15
00841731137951TITANEX TH-DT72026-05-15
00841731137968TITANEX TH-DT82026-05-15
00841731138095TITANEX ART-KW2-1902026-05-15
00841731138101TITANEX ART-KWS-222026-05-15
00841731138118TITANEX ART-DTH-652026-05-15
00841731138125TITANEX ART-STP-492026-05-15
00841731138132TITANEX ART-DBC-492026-05-15
00841731138149TITANEX ART-RT-T252026-05-15
00841731138156TITANEX ART-VZO-152026-05-15
00841731140777TITANEX AZ-D130-262026-05-15
00841731140784TITANEX AZ-DT10-CR2026-05-15
00841731141910TITANEX AZ-D150-332026-05-15
00841731141927TITANEX AZ-DT15-CR2026-05-15

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