FDA.reportPublic FDA data

Vilex Jones Fracture

Primary DI
00841731122575
Brand
Vilex Jones Fracture
Company
VILEX LLC
Model
JF55-70T
Device description
Screw, Jones 5.5x70mm Solid, Ti
Published
2019-08-12
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

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
00841731122575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731122575008417311225758417311225750841731122575

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
03700569653873NANEWCLIP TECHNICSHWC2026-11-05
03700569658274NANEWCLIP TECHNICSHWC2026-11-05
03700569658281NANEWCLIP TECHNICSHWC2026-11-05
03700569667931NANEWCLIP TECHNICSHWC2026-11-05
03700569667948NANEWCLIP TECHNICSHWC2026-11-05
03700569667955NANEWCLIP TECHNICSHWC2026-11-05
03700569667962NANEWCLIP TECHNICSHWC2026-11-05
03700569667979NANEWCLIP TECHNICSHWC2026-11-05
03700569667986NANEWCLIP TECHNICSHWC2026-11-05
03700569667993NANEWCLIP TECHNICSHWC2026-11-05
03700569668006NANEWCLIP TECHNICSHWC2026-11-05
03700569668013NANEWCLIP TECHNICSHWC2026-11-05
03700569668020NANEWCLIP TECHNICSHWC2026-11-05
03700569668037NANEWCLIP TECHNICSHWC2026-11-05
03700569668044NANEWCLIP TECHNICSHWC2026-11-05
03700569668051NANEWCLIP TECHNICSHWC2026-11-05
03700569668068NANEWCLIP TECHNICSHWC2026-11-05
03700569668075NANEWCLIP TECHNICSHWC2026-11-05
03700569668082NANEWCLIP TECHNICSHWC2026-11-05
03700569668099NANEWCLIP TECHNICSHWC2026-11-05
03700569668105NANEWCLIP TECHNICSHWC2026-11-05
03700569668112NANEWCLIP TECHNICSHWC2026-11-05
03700569668129NANEWCLIP TECHNICSHWC2026-11-05
03700569668136NANEWCLIP TECHNICSHWC2026-11-05
03700569668143NANEWCLIP TECHNICSHWC2026-11-05
03700569668150NANEWCLIP TECHNICSHWC2026-11-05
03700569668167NANEWCLIP TECHNICSHWC2026-11-05
03700569668174NANEWCLIP TECHNICSHWC2026-11-05
03700569668181NANEWCLIP TECHNICSHWC2026-11-05
03700569668198NANEWCLIP TECHNICSHWC2026-11-05