FDA.reportPublic FDA data

Vilex Fibula Tool

Primary DI
00841731122032
Brand
Vilex Fibula Tool
Company
VILEX LLC
Model
ZF-T10
Catalog number
ZF-T10
Device description
Driver, Fibula T10 Long
Published
2018-08-20
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
HSBRod, Fixation, Intramedullary And Accessories
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HXXScrewdriverOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151456000Small Bone Nail ImplantVilex IN Tennessee, Inc.2015-10-29HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731122032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731122032008417311220328417311220320841731122032

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
00841731132642REDEMPTION Beaming SystemRPT80-40T-24RPT80-40T-242026-11-03
00841731132659REDEMPTION Beaming SystemRPT80-45T-24RPT80-45T-242026-11-03
00841731132666REDEMPTION Beaming SystemRPT80-50T-24RPT80-50T-242026-11-03
00841731132673REDEMPTION Beaming SystemRPT80-55T-24RPT80-55T-242026-11-03
00841731132680REDEMPTION Beaming SystemRPT80-60T-24RPT80-60T-242026-11-03
00841731132697REDEMPTION Beaming SystemRPT80-65T-24RPT80-65T-242026-11-03
00841731132703REDEMPTION Beaming SystemRPT80-70T-24RPT80-70T-242026-11-03
00841731132710REDEMPTION Beaming SystemRPT80-75T-24RPT80-75T-242026-11-03
00841731132727REDEMPTION Beaming SystemRPT80-80T-24RPT80-80T-242026-11-03
00841731132734REDEMPTION Beaming SystemRPT80-85T-24RPT80-85T-242026-11-03
00841731132741REDEMPTION Beaming SystemRPT80-90T-24RPT80-90T-242026-11-03
00841731132758REDEMPTION Beaming SystemRPT80-95T-24RPT80-95T-242026-11-03
00841731132765REDEMPTION Beaming SystemRPT80-100T-24RPT80-100T-242026-11-03
00841731132772REDEMPTION Beaming SystemRPT80-105T-24RPT80-105T-242026-11-03
00841731132789REDEMPTION Beaming SystemRPT80-110T-24RPT80-110T-242026-11-03
00841731132796REDEMPTION Beaming SystemRPT80-115T-24RPT80-115T-242026-11-03
00841731132802REDEMPTION Beaming SystemRPT80-120T-24RPT80-120T-242026-11-03
00841731132819REDEMPTION Beaming SystemRPT80-125T-24RPT80-125T-242026-11-03
00841731132826REDEMPTION Beaming SystemRPT80-130T-24RPT80-130T-242026-11-03
00841731132833REDEMPTION Beaming SystemRPT80-135T-24RPT80-135T-242026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800308486047INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.HXX2026-11-04
08800308486054INNOVERSE SPINAL SYSTEMCG MedTech Co.,Ltd.HXX2026-11-04
00841731133717REDEMPTION Beaming SystemVILEX LLCHXX2026-11-03
00841731133724REDEMPTION Beaming SystemVILEX LLCHXX2026-11-03
08800322759233Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08800322759240Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809695602887Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809974815953Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
08809974816004Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-11-03
B382SD91449311010Surgical DirectSurgical Direct, Inc.HXX2026-10-28
08800089487820Surgical InstrumentJeil Medical CorporationHXX2026-10-26
00190776436933MillenniumAvalign Technologies, Inc.HXX2026-10-23
09120125220242Shark Screw® driver cutsurgebright GmbHHXX2026-10-22
00199150076451Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080373Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080380Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080397Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00824846013600Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HXX2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HXX2026-10-19
M97012000112300DynaNailMedshape, Inc.HSB2026-10-16
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.HXX2026-10-14
08056693086397ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
08056693086403ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
08056693086410ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
00817867021044PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021051PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021068PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021075PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021082PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01