FDA.reportPublic FDA data

Vilex Fibula Nail

Primary DI
00841731119476
Brand
Vilex Fibula Nail
Company
VILEX LLC
Model
FXS35-45T
Catalog number
FXS35-45T
Device description
Screw, Fibula Nail 3.5x45mm Ti V. Purple
Published
2018-05-03
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
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
00841731119476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731119476008417311194768417311194760841731119476

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
M97012000112300DynaNailMedshape, Inc.HSB2026-10-16
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
00817867021099PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021105PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021112PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021129PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021136PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021143PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021150PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021167PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021174PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021181PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021198PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021204PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021211PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021228PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021235PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021242PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021259PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021266PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021273PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021280PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021297PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01